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

Model Number BEQ-HMOD70000-USA #

Device Problem Gas/Air Leak (2946)

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

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) requested the product for investigation but the product was not available.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated already was performed and no similar complaints were found.Thus the reported failure could not be confirmed.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.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 conducted.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

According to the customer: oxy with lot # 70123613, which was noted to have a similar issue during priming by another nurse.Eventually they were able to get the air out and put the patient on support.Less than 12 hours later, they noted unusual thrombus formation and unusual blood path, this is unknown whether it is related.The circuit was changed without incident.No harm to the patient was reported.While blood priming the venous side of the oxygenator completely blood primed then for an unexplained reason suddenly de primed with air about 1 in down the venous side of the oxygenator.The circuit was eventually completely blood primed, though the venous air at the top of the oxygenator remained.Volume was added to the venous side of the circuit in an attempt to help force the air out.The pt was successfully placed on ecmo and the oxygenator showed no gas exchange issues.Thrombus formation noted in the same areas that the blood prime the previous day was noted to have stagnation.The team felt this amount of thrombos could be a rik for the patient.The oxy was exchanged without issues.Internal reference: (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: 8101759
• MDR Text Key: 129190051
• Report Number: 8010762-2018-00308
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2020
• Device Model Number: BEQ-HMOD70000-USA #
• Device Catalogue Number: 701067859
• Device Lot Number: 70123613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2018
• 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
• Patient Outcome(s): Required Intervention