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

Model Number 701051713 - ROTAFLOW EN/NORTH AM US-PLUG ICU

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from us that biomed (authorized person in the hospital) noticed a head error on rotaflow console.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The unit has been sent to the national repair center on rma # (b)(4).According to the service order (b)(4) dated on (b)(6) 2020 any setting above 1000rpm, a signal head error appears and the machine locks out.I tried swapping a different drive from a working machine, and the same alarm occured.I then swapped this drive to another machine, and the same alarm occured.Both the drive and the console seem to be associated with the error.This machine will need to go to depot for repair.No repair will be made under this service order.The machine is taken out of service and the customer requested a rental.On (b)(6) 2020 no rental is currently available, so i'm going to have an empty container shipped, to get this machine in for repair.Closing this out and depot will create a service order for the repair, and the charges will be billed by depot.According to the service report (b)(4) dated on (b)(6) 2020 the error is coming from both the rotaflowdrive (rfd) and the rotaflowconsole (rfc).The rfc needs a control board and the rfd has to be sent to germany for repair under (b)(4).The drive will be handle in complaint (b)(4).On the rotaflowconsole the control board was replaced and tested per service manual.All tests passed.Additional the 2 year maintenance was performed.Calibration check, full functional test and safety check as per the service manual.All tests passed.The following most possible root cause could be determined for the head error: 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 contain detailed descriptions to prevent an ¿error head¿.The reported "head error" was noticed by the biomed (authorized person) in the hospital and could be confirmed.The device was directly involved in the incident.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The ocurrence 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.

• 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: 9837682
• MDR Text Key: 204926448
• Report Number: 8010762-2020-00109
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701051713 - ROTAFLOW EN/NORTH AM US-PLUG ICU
• Device Catalogue Number: 701051712
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Patient Sequence Number: 1