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

Model Number HMOD 70000-USA

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was not available for investigation; therefore manufacturers' laboratory investigation was not possible.No product lot # was provided; therefore it was not possible to check if the specific product is still within capa (b)(4) range (effectiveness check).Furthermore it was not possible to perform a dhr review.Trend search: a trackwise trend search was performed for p/n 70105.3815 failure code d-leakage gas outlet and 7 complaints were found.Three of them are already closed and were referencing to capa (b)(4).A sap trend search was performed for p/n 70105.3815 failure code 0101 leakage gas outlet and 34 additional complaints were found to be referencing to capa (b)(4).Based on this the failure is known and was thoroughly investigated under capa (b)(4).The investigation has identified that the root cause is due to the manufacturing process of the raw material fibers used in the oxygenator.If, during the surface pre-treatment, a system malfunction results in a system results in a system stop, the entire length of the fiber is not properly treated to modify the surface tension.If these untreated fibers are present in the epoxy area of the oxygenator, it is not properly fixed in the epoxy.When this occurs, the fibers are able to ¿shrink out¿ of the epoxy and result in the reported leakage.The raw material manufacturer has initiated steps to repeat the surface pre-treatment to ensure that the proper surface tension is present on the entire length of the fibers.

Event Description

According to the customer: "blood leak from exhaust (gas out) port.The product was exchanged during patient treatment.No patient consequences were reported." (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: 6148614
• MDR Text Key: 61868370
• Report Number: 8010762-2016-00709
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HMOD 70000-USA
• Device Catalogue Number: 70105.3815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/06/2016
• 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