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 Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from a customer from the us that on the rotaflow drive the error message ¿head error¿ occurred.No more details provided.No indication of actual, or potential for harm, or death was reported.Complaint id: (b)(4).

Manufacturer Narrative

An head eror occurred in the rotaflow drive.The affected rotaflow drive with serial number (b)(6) has been sent back under rma#42511 for investigation and repair to the manufacturer emtec.2020-11-10: the concerned drive was received by maquet.2020-11-16: the failure head error could be confirmed after testing in the service department.Drive send to emtec.Additional it was found that wrong screws on the drive and oil is missing on the holder.2020-11-18: drive send to emtec same failure was already investigated at emtec report no.Rma2020-10009 on 2020-02-24 (complaint (b)(4); rma#39725): the defective drive was sent to the supplier em tec for further root cause investigation: 2020-02-24: em tec report no.Rma2020-10009: the reported head error is a result of wrong handling of the user see below causes.The reported failure could be reproduced and confirmed.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, chapter 8.1.2 contain detailed descriptions to prevent an ¿error head¿.The reported failure "head error" could be confirmed.The device was directly involved in the event.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: 10688747
• MDR Text Key: 211650344
• Report Number: 8010762-2020-00344
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• 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: 70102.2161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Date Manufacturer Received: 11/20/2020
• Patient Sequence Number: 1