MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Maquet cardiopulmonary (b)(4) requested the product back for investigation. A supplemental medwatch will be submitted as soon as further information becomes available. Additional information: the product mentioned is a vkmo and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k082117.

Event Description

"unstable patient admitted with very high white blood cell count (>200). A long procedure ensued, including pericarditis, valve replacement and ao replacement (lots of vasopressors given) which ended up with a 5 hour bypass time. At 3 hours the oxygenator began to fail, so the fio2 was increased to 100% but the po2 was still dropping. They decided to swap out the oxygenator at this point. Suspected clogging of the fibers due to leucocytosis, with rapid lipid dropout from the patient. " (b)(4).

Manufacturer Narrative

The oxygenator was returned to maquet cardiopulmonary (b)(5) for evaluation. The oxygenator was investigated in the decontamination/complaints laboratory. On the blood inlet side and on the blood outlet side, no clots were visible, and none were flushed out. The oxygenator was cleaned with sodium hypochlorite. No leakage was found. The oxygenator was sent to the qa laboratory for performance tests. In the qa-laboratory, the oxygenator was tested for its gas (o2 and co2) exchange and pressure drop performance (delta p measurement) according to lv009 with bovine blood from 2017-01-23 (test date was also 2017-01-23). The results of the tests showed that the gas exchange performance is within specified limits, but the product failed the pressure drop test. The oxygenator was then returned to the decontamination/complaints laboratory. All four sides of the oxygenator were removed. The filter mats were not damaged or otherwise marked or discolored. No other anomalies were found. There were 74 filter mats on the gas side, and this is within specification (a count of 72, 74, or 76 is specified). The therapy application manager was consulted for a clinical assessment of the case. The clinical staff from (b)(6) suspected clogging of the fibers due to leukocytosis. Despite the fact that there are no details available about blood parameters, the results from the performance tests from the qa laboratory supports the customer's hypothesis that the higher than expected pressure drop could be a result of leukocytosis, and this is the most likely reason for the reduced pressure drop performance. A dhr review found no issues.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET
• 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: 5545137
• MDR Text Key: 42492768
• Report Number: 8010762-2016-00236
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082117
• 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,Followup
• Report Date: 02/13/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/03/2017
• 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