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

Model Number BEQ-HMOD70000-USA

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/24/2016

Event Type  malfunction  

Manufacturer Narrative

Additional incident information was requested, but not yet provided.A trackwise trend search was performed for p/n 70105.3824, failure code: clotting and no similar incident was found.A sap trend search was performed for p/n 70105.3824, failure code clotting, (b)(4) similar complaints were found out of period 09/2011 to 03/2014, no additional complaints found starting from afterwards until now (2016-10-17).Due to this information no systemic issue could be determined.Clotting is a known phenomenon and has been investigated in a previous complaint.Based on a previous complaint investigation the cause of this failure was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.Dhr review: no oxygenator serial number was provided up to date, therefore a dhr review of the product in question was not possible at this time.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.

Event Description

"customer believes the units in question may have clotted off.Two of the units were used in the last 48hrs the unit was switched out.This is the 1st of the units listed in the original complaint".(b)(4).Refer to complaint # (b)(4) for the second unit, will be reported separately.

• 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: 6034693
• MDR Text Key: 57798745
• Report Number: 8010762-2016-00633
• 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: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 701053824
• Device Lot Number: 70111376
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Date Device Manufactured: 04/01/2016
• 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