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

Model Number BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.

Device Problem Improper Flow or Infusion (2954)

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

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

Maquet (b)(4) requested the product in question for further investigation in the laboratory of the manufacturer but not received yet.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the us customer: they had a patient that could not be weaned from cp bypass post surgery and they attempted support with their "conventional support circuit" which is a medtronic tubing pack with our quadrox-id added.Initially flow was good and then slowed quickly.Dr.Decided to replace the circuit with another of the same circuit, same initial good flow and then again quickly slowed.3rd attempt was to go with cardiohelp and hls.Patient was started on therapy with no additional problems.It was stated that the problem could have been caused by any number of factors but thought that we should inspect the oxygenators.Two oxygenators were used before the customer changed to hls support.No harm to the patient was reported.Complaint id: (b)(4).

Manufacturer Narrative

The two affected oxygenators were investigated in the laboratory of the manufacturer on 2019-08-22.A visual inspection was performed on both oxygenators.On the first affected oxygenator with the serial number (b)(4) clots on the blood out let side detected.On the second oxygenator with serial number (b)(4) no clots have been detected.Failure could be confirmed on the oxygenator with s/n (b)(4) but failure not confirmed at the oxygenator with s/n (b)(4).The most probable root cause for the confirmed clots is unknown at this time.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8886860
• MDR Text Key: 154150809
• Report Number: 8010762-2019-00242
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2021
• Device Model Number: BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.
• Device Catalogue Number: 701067859
• Device Lot Number: 70130837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 08/29/2019
• Patient Sequence Number: 1