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

Model Number 701022161 - ROTAFLOW DRIVE UNIT, BLUE

Device Problem Device Sensing Problem (2917)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from the us that the bubble sensor doesn't work on the rotaflow drive.Upon inspection of the rfd connector found a pin missing in the connector.Complaint id: (b)(4).

Manufacturer Narrative

The incident was noticed during inspection of the rotaflow drive.The affected rotaflow drive was shipped to germany for repair by the manufacturer emtec under rma#40385.Incoming goods in rastatt (b)(6)2020 functionaltest in rastatt (b)(6)2020 failure not confirmed sent to emtec (b)(6)2020 back from emtec(b)(6)2020 outgoing goods (b)(6)2020 according to the service report rma2020-10052 from emtec dated on (b)(6)2020 functional test performed to reproduce the reported failure.The drive was connected to the test console by emtec and test started.The console was started in the stand alone mode.The speed increases so far to be able to trigger a bubble alarm in the test circuit.The tube is narrowed a little so that bubbles are activated, the drive stops with a bubble alarm.Carry out the experiment several times, always with a bubble alarm.Failure could not be reproduced/confirmed.About the described missing pin.By version of the serial number (b)(6) it is normal that pin 8 is missing and this has no influences of the functionalty the rotaflow drive.Newer versions of drives have a blind pin.Drive passed all tests.The rotaflow drive was tested in rastatt according to the service protocol (see service report 10478149 dated on (b)(6)2020).The rotaflow risk analysis version v06 (dms# 2023689) chapter h1.1.1.18 was reviewed on (b)(6)2020 with the following outcome: the most possible causes for the reported failure "bubble sensor doesn´t work" could be determined as: bubble/flow sensor failure, e.G.: * malfunction of bubble/flow sensor electronics * dried contact gel * user forgot renewing contact gel * mechanical defects (impact) * sensor not detected although sensor is connected * device used out of specification * software error the reported failure "bubble sensor doesn´t work" occurred during inspection and could not be confirmed.The device was directly involved in the incident.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: 9705292
• MDR Text Key: 179303539
• Report Number: 8010762-2020-00060
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701022161 - ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 04/20/2020
• Patient Sequence Number: 1