MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CENTRIFUGAL PUMP WITH FLOWPROBE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number BE-RF-32#CENTRIFUGAL PUMP WITH FLOWPROBE

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up emdr will be submitted when additional information becomes available.

Event Description

After 7 days of use, blood came out of the centrifugal pump.Probably a tear.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the centrifugal pump was leaking during patient treatment.The pump was investigated by the getinge laboratory on 2021-03-10.During visual inspection a crack at the upper pump housing was detected.No further damages were noted.If during connection of the tube to the pump too high forces are applied material damages in the form of cracks or fractures can be caused.These can then lead to the described leakage during use due to further external influences (e.G.Temperature, cleaning agents, mechanical impact).The production records of the affected rf-32 centrifugal pump (dms# (b)(4)) were reviewed on 2021-01-12.According to the final test results, all pumps passed the tests as per specifications.Production related influences can be excluded.Based on the investigation results the reported failure "leakage" could be confirmed.The most probable root causes is a mechanical damage caused by external influences (high forces, temperature, cleaning agents, mechanical impact).The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(4).

• Brand Name: CENTRIFUGAL PUMP WITH FLOWPROBE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11300653
• MDR Text Key: 230955811
• Report Number: 8010762-2021-00107
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K080470
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-RF-32#CENTRIFUGAL PUMP WITH FLOWPROBE
• Device Catalogue Number: 701002804
• Device Lot Number: 70133339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1