MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-PLS 2050

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The product was disposed off by the hospital; therefore a manufacturer laboratory investigation was not possible.The failure is known to mcp and was thoroughly investigated by capa (b)(4).Corrective and preventive actions have been established in capa (b)(4) based on the root cause analysis: development and implementation of an optical inspection of the raw material (membrane).Development and implementation of a new punching process.Improvement of the packaging of the membrane rolls at the supplier.Prevention of pressures above the tolerance in pressure test units (revision/enhancement of basic operating procedures).Full further investigation and all other actions and the effectiveness thereof will be carried out as part of the capa investigation.The corrective and preventive actions above based on the rca have a projected timeframe for completion by end of october 2017.

Event Description

There was leakage from the de-airing valve of the oxygenator during the patient use.The product was exchanged without severe consequences for the patient.(b)(4).Also related to record (b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6719157
• MDR Text Key: 80403659
• Report Number: 8010762-2017-00233
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: BE-PLS 2050
• Device Catalogue Number: 701027818
• Device Lot Number: 70113193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1