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

Model Number OXYGENATOR, CARDIOPULMONARY BYPASS

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested to return for manufacturers laboratory investigation, but has not been received yet.The investigation is still pending.A supplemental medwatch will be submitted when further information becomes available.

Event Description

The customer detected a quadrox-id that had a black piece of material in it.Was not used on a patient.No harm.No further information available at this time.(b)(4).

Manufacturer Narrative

During visual inspection of the product no black piece of material was detected.The product was rinsed and the water did run through a strainer, no foreign matter was detected.Based on this a confirmation of the failure was not possible.The most probable cause of the reported failure could not be determined.Trend search: a sap trend search was performed for p/n 70105.3824 failure code 0710 particle and one similar complaint was found which is already closed.A trackwise trend search was performed for p/n 70105.3824 failure code d-dirty/foreign particle and no similar complaint was found.Due to this information no systemic issue could be determined.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(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: 5755740
• MDR Text Key: 49129767
• Report Number: 8010762-2016-00412
• 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,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OXYGENATOR, CARDIOPULMONARY BYPASS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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