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

Model Number ROTAFLOW DRIVE UNIT, BLUE

Device Problem Device Sensing Problem (2917)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2020

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 the us that rotaflow drive not making connection causing bubble detector fault.Occurred during priming.No harm to any person reported.The rotaflow drive will be sent to the getinge repair center.(b)(4).

Manufacturer Narrative

The initial reported failure by the customer "bubble sensor defective" occurred during priming.The rotaflow pump head has been send to the getinge repair center with rma# 6932002195.According to the rma#41414 prepared by the repair center us "unit came into the repair center with a complaint that said "pump head not making connection causing bubble detector fault.".Tested rotaflow drive and ran fine.The customer rotaflow drive gives a bubble error because it reports a head error when begin to run the rotaflow drive.Also the lpm won't zero." the drive has been send to germany for repair by the manufacturer emtec under rma#41414.Incomining goods in rastatt 2020-07-17 functionaltest in rastatt 2020-07-24 -> reported head error confirmed but the failure "flow could not be set to zero" could not be confirmed.The flow can be reset to zero.Drive have to send to emtec send to emtec 2020-07-31 back from emtec 2020-09-01 functionaltest after emtec in rastatt 2020-09-01 outgoing goods 2020-09-01 according to the service report rma2020-10251 from emtec dated on 2020-08-27 the flow can be reset to zero.The reported head error could be reproduced.Ild on the electrical platine detected as defective.Probable root cause: hot-plug.The ild was replaced.Rotaflow drive passed all tests.The following most possible root cause could be determined for the head error: 1.The head error is caused by the hot plug.When the device is in operation and the power plug is plugged in or out the head error occurs and the rota flow drive and / or the control board is damaged.As a result the rota flow drive and / or the control board has to be replaced.Furthermore, the instructions for use of the rotaflow system, see rotaflow system user manuel, mcv-ga-10000703-de-11, chapter 8.1.2 contain detailed descriptions to prevent an ¿error head¿.According to the service report 10478443 dated on 2020-09-01 the rotaflow drive was tested according to the current service protocol.The initial reported failure by the customer "bubble sensor fault" could not be confirmed.The occurred head error 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: 10119673
• MDR Text Key: 194124666
• Report Number: 8010762-2020-00189
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Date Manufacturer Received: 09/02/2020
• Patient Sequence Number: 1