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

Model Number BEQ-HMOD70000-USA #

Device Problem Defective Component (2292)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/17/2018

Event Type  malfunction  

Manufacturer Narrative

The product was requested for return to the manufacturer for laboratory investigation but was not received yet.The investigation is still pending.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that a patient was on a circuit with a quadrox id and it failed very quickly.Customer changed it out within 4 hours.No harm to the patient was reported.Additional information: the patient was placed on therapy at 1333 with the initial oxygenator.At 1430 it was noted that the patient's pao2's remained lower than anticipated 43.A post membrane gas was checked with a result of 299 on 9 lpm of sweep gas flow and 100% fio2.Additional management strategies were tried for a brief period of time.A post oxygenator pump gas was rechecked ~1500 with a result of 230, and again rechecked at 1530 with a result of 120 on the pao2 arterial pump sample.The decision was then made by the physician to change out the oxygenator.Which was done.The patient did sustain low pao2 and saturations in the mid to low 80's for approximately 4 hours while trouble shooting and diagnostic items were being completed.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa (importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).The product was requested for return to the manufacturer for laboratory investigation.The returned oxygenator was investigated in the laboratory of the manufacturer.A quadrox-id adult was sent back.The oxygenator was contaminated.In the visual inspection, clots on the blood inlet side were detected and documented.Oxygenator was cleaned with sodium hypochlorite.No more clots visible.A readjustment test is not necessary to built new clots with water or priming solution is not possible.Further investigation steps are momentarily not possible to be executed due to work safety issues in the complaint laboratory.Maquet cardiopulmonary is currently in the mitigation of this issue.When further investigation steps can be executed again, these investigations will be performed and the complaint file will be updated accordingly.Thus the failure could be confirmed.The most probable root cause at this time could be the detected clots which were raised out of the oxygenator in the lab during investigation.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.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

Internal reference: (b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8130066
• MDR Text Key: 129897591
• Report Number: 8010762-2018-00317
• 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
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2020
• Device Model Number: BEQ-HMOD70000-USA #
• Device Catalogue Number: 701067859
• Device Lot Number: 70123603
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention