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Tubing, Pump, Cardiopulmonary Bypass（DWE）
体外循環用ポンプチューブ この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。
48 件
直近 2020.03.04
21 件
0 件
1,863 件
分類情報
| Product Code | DWE |
|---|---|
| デバイス名 | Tubing, Pump, Cardiopulmonary Bypass 体外循環用ポンプチューブ この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。 |
| デバイスクラス | クラス II |
| 21 CFR 規制番号 | 870.4390 |
| 審査区分 | 510(k)（市販前届出） |
| 医療専門分野 | 循環器 |
| 定義 | － |
| フラグ | 該当なし |
| AI分析 | 本機器は、心肺バイパス（体外循環）装置においてポンプと接続して血液を送るためのチューブです。米国ではクラスIIに分類されており、市販前届出（510(k)）により既存の同等品との実質的同等性を示すことで、市販が認められる審査区分となっています。 米国市場での動向 本製品コードは510(k)による届出が累計約20件あり、18社が参入していますが、直近5年間の届出は1件にとどまります。不具合報告は累計約1,900件で、大半がMalfunction（不具合）であり、死亡80件、傷害約190件が含まれ、主な問題としてFluid/Blood Leak（液体・血液漏れ）、Material Separation（部材の分離）、Obstruction of Flow（流路閉塞）が挙げられています。回収は累計約50件で、クラスIは確認されておらず、クラスIIが約30件、クラスIIIが約5件を占め、直近5年間の回収はなく、最新の回収開始は2019年7月です。 この分析は公開データ（openFDA・JMDN 対応情報）をもとに AI が生成した参考情報です。市場データは2026年8月時点の集計に基づきます。 |
類似の国内医療機器（自動推定）
FDA デバイス分類と JMDN 英語名の名称・定義文の類似度から機械的に推定した候補です。日米の当局が定めた公的な対応関係ではなく、参考情報としてご覧ください。
| No. | 類別 | 一般的名称 | 品目数 | 企業数 | 年間総出荷額 | 成長率 | 平均価格 | 国産比率 |
|---|---|---|---|---|---|---|---|---|
| 1 | 内臓機能代用器 | 人工心肺用ローラポンプクラスⅢ | 1 | 1 | — | — | — | — |
| 2 | 理学診療用器具 | 電動式心肺人工蘇生器クラスⅢ | 8 | 7 | — | — | — | — |
| 3 | 理学診療用器具 | 手動式心臓ポンプクラスⅢ | 4 | 3 | 0.47 億円/年 | -26.4% | 10.89 万円/個 | 70.1% |
| 4 | 医療用嘴管及び体液誘導管 | 循環補助用心内留置型ポンプカテーテルクラスⅣ | 6 | 2 | — | — | — | — |
| 5 | 内臓機能代用器 | 人工心肺用回路システムクラスⅢ | 19 | 10 | 131.2 億円/年 | +2.0% | 6.89 万円/個 | 86.3% |
FDA のデバイスクラスは 3 段階（クラス I〜III）、日本の医療機器は 4 段階（クラス I〜IV）で分類されており、 1 対 1 では対応しません。 リスク区分の考え方が異なるため、参考情報としてご利用ください。
米国での回収・承認・不具合報告
米国回収
全 48 件| 回収番号 | クラス | 回収開始日 | 企業 | 理由 | ステータス |
|---|---|---|---|---|---|
| Z-1389-2020 DWE | クラス III（軽微） | 2019.07.03 | LivaNova USA Inc. | Perfusion tubing pack was packaged with the incorrect cuvette. | 終了 |
| Z-0664-2018 DWE | クラス III（軽微） | 2017.12.19 | LivaNova USA | The product is labeled with the incorrect expiration date. | 終了 |
| Z-1733-2018 DWE | クラス II | 2017.10.19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow. | 終了 |
| Z-1725-2018 DWE | クラス II | 2017.10.19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow. | 終了 |
| Z-1720-2018 DWE | クラス II | 2017.10.19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow. | 終了 |
| Z-1718-2018 DWE | クラス II | 2017.10.19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow. | 終了 |
| Z-1717-2018 DWE | クラス II | 2017.10.19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow. | 終了 |
| Z-1709-2018 DWE | クラス II | 2017.10.19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow. | 終了 |
| Z-2180-2018 DWE | クラス II | 2017.07.27 | Datascope Corporation | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. | 終了 |
| Z-2179-2018 DWE | クラス II | 2017.07.27 | Datascope Corporation | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. | 終了 |
| Z-2178-2018 DWE | クラス II | 2017.07.27 | Datascope Corporation | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. | 終了 |
| Z-2798-2017 DWE | クラス II | 2017.06.29 | Sorin Group USA, Inc. | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers. | 終了 |
| Z-2797-2017 DWE | クラス II | 2017.06.29 | Sorin Group USA, Inc. | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers. | 終了 |
| Z-2796-2017 DWE | クラス II | 2017.06.29 | Sorin Group USA, Inc. | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers. | 終了 |
| Z-2795-2017 DWE | クラス II | 2017.06.29 | Sorin Group USA, Inc. | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers. | 終了 |
| Z-2794-2017 DWE | クラス II | 2017.06.29 | Sorin Group USA, Inc. | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers. | 終了 |
| Z-2793-2017 DWE | クラス II | 2017.06.29 | Sorin Group USA, Inc. | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers. | 終了 |
| Z-2792-2017 DWE | クラス II | 2017.06.29 | Sorin Group USA, Inc. | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers. | 終了 |
| Z-2791-2017 DWE | クラス II | 2017.06.29 | Sorin Group USA, Inc. | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers. | 終了 |
| Z-2790-2017 DWE | クラス II | 2017.06.29 | Sorin Group USA, Inc. | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers. | 終了 |
510(k)（市販前届出）
全 21 件| No. | 番号 | 機器名 | 申請者 | 決定日 | 種別 | 概要 |
|---|---|---|---|---|---|---|
| 1 | K233702 | SMARxT Tubing and Connectors | LivaNova USA, Inc. | 2024.08.08 | 通常（Traditional） | |
| 2 | K150542 | Terumo Pump Tubing | Terumo Cardiovascular Systems Corporation | 2015.05.01 | 特別（Special） | |
| 3 | K142607 | AngioVac Circuit | Angiodynamics | 2014.12.11 | 通常（Traditional） | |
| 4 | K092486 | VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT | Vortex Medical, Inc. | 2009.08.28 | 通常（Traditional） | |
| 5 | K080592 | HLM TUBING SET WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | 2008.09.11 | 特別（Special） | |
| 6 | K053025 | JOSTRA HLM TUBING SET | Maquet Cardiopulmonary, AG | 2005.11.10 | 通常（Traditional） | |
| 7 | K022857 | PUMP TUBING WITH X-COATING | Terumo Cardiovascular Systems Corporation | 2002.09.19 | 特別（Special） | |
| 8 | K013578 | PUMP TUBING | Terumo Cardiovascular Systems Corp. | 2002.01.22 | 通常（Traditional） | |
| 9 | K993189 | CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING | Terumo Corp. | 2000.03.01 | 通常（Traditional） | |
| 10 | K993062 | CHEST DRAINAGE TUBING | Olson Medical Sales, Inc. | 1999.12.10 | 通常（Traditional） | |
| 11 | K981613 | COBE SMARXT TUBING AND CONNECTORS | Cobe Cardiovascular, Inc. | 1998.10.26 | 通常（Traditional） | |
| 12 | K923231 | CARDIO-PAK BASIC PUMP PACK | Cardio-Med-Associates, Inc. | 1993.07.09 | 通常（Traditional） | － |
| 13 | K905686 | SARNS TEMPERATURE PROBE AND CONNECTOR | 3M Health Care, Sarns | 1991.02.25 | 通常（Traditional） | － |
| 14 | K902845 | GENTLE HEADER | Enhanced Perfusion Systems, Inc. | 1990.12.03 | 通常（Traditional） | － |
| 15 | K894721 | TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE | The Traumafuse Co. | 1989.10.20 | 通常（Traditional） | － |
| 16 | K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | Sterile Design, Inc. | 1984.10.19 | 通常（Traditional） | － |
| 17 | K842044 | SARNS EVACUPLEGE CATHETER | 3M Health Care, Sarns | 1984.08.10 | 通常（Traditional） | － |
| 18 | K810924 | MEDRAD HIGH PRESSURE CONECTING TUBE | Medrad, Inc. | 1981.04.17 | 通常（Traditional） | － |
| 19 | K803277 | TYGON TUBING | Electromedics, Inc. | 1981.01.13 | 通常（Traditional） | － |
| 20 | K801394 | CARDIOPULMONARY BYPASS PUMP TUBING | Texas Medical Products, Inc. | 1980.06.30 | 通常（Traditional） | － |
出典の openFDA は各 510(k) の主要（primary）product code のみを収録しているため、副次コードを含む FDA 公式データベースの検索結果とは件数が異なる場合があります。 FDA 510(k) データベースで確認
PMA（市販前承認）
この product code の PMA 情報はありません。
不具合報告（MAUDE）トレンド
米国不具合報告検索で詳しく見る出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
報告の存在は、機器と事象の因果関係を意味しません。報告件数を機器間の不具合発生率の比較に用いることはできません。
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。
出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
取得日: 2026.09.28
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。