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

Model Number VKMO 50000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested to return for manufacturers laboratory investigation but it was scrapped.Maquet cardiopulmonary (b)(4) is aware of similar complaints showing a similar malfunction.Therefore maquet cardiopulmonary (b)(4) has initiated a capa process ((b)(4)) to address the appropriate corrective and preventive action.Corrective and preventive actions have been established in (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 july 2017.Please see this report as the final report.

Event Description

According to the customer: 'leakage of water from the vent port of the small adult oxygenator during priming.Oxygenator was changed and the procedure was completed.' (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: 6129719
• MDR Text Key: 61291605
• Report Number: 8010762-2016-00690
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K090689
• 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: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2017
• Device Model Number: VKMO 50000
• Device Catalogue Number: 701064518
• Device Lot Number: 92184499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2016
• Date Device Manufactured: 10/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1