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

Model Number HMOD 70000-USA

Device Problems Device Operates Differently Than Expected (2913); Pressure Problem (3012)

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

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested but not received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: quadrox-d oxygenator developed a high trans-membrane pressure during initiation of support for the patient.Oxygenator was struggling to work and the unit was removed and replaced with a different lot of same type of oxygenator.No additional details are known at this time.(b)(4).

Manufacturer Narrative

(b)(4).A quadrox-id adult oxygenator was returned to the factory and investigated in the decontamination / complaints laboratory.No clots were visible on the blood inlet and blood outlets sides.No blood clots were visible while flushing out the oxygenator with water.On three luer locks (blood inlet connector, blood outlet connector, and blood outlet cover), cracks were found and documented.Note that on all three luer locks, non-genuine protective cap were screwed on.A 1-way tap was glued onto each luer lock so that further tests could be carried out.A leakage test on the blood side was carried out.All three luer locks were watertight.It should be noted that there was no mention of any cracks, damage or leaks in the customer report.The non-genuine protective caps could explain the luer locks were cracked.For further examination, the product was forwarded to the qa laboratory.In the qa laboratory, the product was tested for its gas exchange performance for o2 and co2, and also a pressure drop test was performed.The product passed all the performance tests and was found to be working as specified.The conclusion from investigation/evaluation of the sample is that the reported issue is not related to device-related factors, and the pressure performance is within specification.A definitive root cause cannot be determined, as it is considered to be clinical in nature, and can have a wide range of causal factors that cannot be established after the event.Based on the investigation and trending for this issue, neither a product-related problem nor a systemic issue is indicated, therefore, no further investigation or action is currently warranted in addition to continued periodic monitoring and the complaint will be closed.

Event Description

Ref.: # (b)(4), customer ref.: (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: 6486168
• MDR Text Key: 72794444
• Report Number: 8010762-2017-00121
• 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: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: HMOD 70000-USA
• Device Catalogue Number: 701053815
• Device Lot Number: 70112505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Date Device Manufactured: 07/01/2016
• 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