MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number MCP00967621#RFD 20-973 ROTAFLOW DRIVE

Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from a customer from (b)(6) that the error ¿txrx¿ occurred on the rotaflow console during test in the laboratory.No patient involvement.No indication of actual or potential for harm or death reported.Complaint id: (b)(4).

Manufacturer Narrative

The reported failure "txrx error" occurred during test in the laboratory.The affected rotaflow drive with s/n (b)(6) was sent back to manufacturer for repair.It was received on 2020-12-10 and during investigation by the service department on 2021-01-11 the reported failure "txrx error" could be reproduced.Thus the drive was sent to the supplier emtec on 2021-01-27 for repair.On 2021-02-16 emtec was able to reproduce the reported failure and the root cause was determined as a cable break of the device, which led to the reported failure.The cable of the rotaflow drive and the flow sensor was replaced by the supplier.Preventive the mc1 and mc2 platine was also replaced.After functional test at getinge service department on 2021-02-22 the device was sent back to the user.A device history review (dhr) was performed and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.Based on these investigation results the reported failure could be confirmed.The occurrence rate was calculated for the reported issue 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: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10940509
• MDR Text Key: 219340735
• Report Number: 8010762-2020-00419
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00967621#RFD 20-973 ROTAFLOW DRIVE
• Device Catalogue Number: 701010875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 02/23/2021
• Patient Sequence Number: 1