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

Model Number BEQ-HMOD30000-USA

Device Problems Complete Blockage (1094); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product is not available for return; therefore an investigation at the laboratory of the manufacturer was not possible.Trend search: a sap trend search was performed for p/n 70105.0330 failure code 0010 clotting and 2 similar complaints were found.A trackwise trend search was performed for p/n 70105.0330 d-clotting outlet side and 6 similar complaints were found.Due to this information no systemic issue could be determined.Similar complaint investigation results: the reported failure is known to mcp and was investigated within a similar complaint with the following results:sample was received by the lab.The unit was tested with bovine blood for gas exchange and pressure drop performance.The unit met all acceptance criteria.Clotting is a known phenomenon and was investigated in previous complaints.The cause of this failure was determined to not be attributed to a device related malfunction.Thus the reported failure could not be confirmed.Based on these results and the information available at this time, the oxygenator in question operated within mcp specifications.

Event Description

According to the customer: clots in corners on arterial side.Ecmo hour 4 arterial side of membrane clot noted at 3 o¿clock and 9 o¿clock.-heparin started at ecmo hr.-heparin off at hr 23.-heparin on at hr 27.-heparin sub therapeutic through most of the ecmo run, ptt 60-100s.-membrane changed at hour 335, electively, delta gradient was the same (per surgeon¿s request).-with new membrane no arterial side clots noted despite sub therapeutic heparin.-patient remains on ecmo.-(b)(6).-flows 400-500 l/min.(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: 6348770
• MDR Text Key: 68377341
• Report Number: 8010762-2017-00056
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• 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: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD30000-USA
• Device Catalogue Number: 701050330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1