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

Model Number ROTAFLOW

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Head error during demo testing.Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was "head error".According to the service order 43490428 dated on (b)(6) 2020 a getinge service technician confirmed the head error.The costumer removed the rotaflow drive cable while the power was one.Resulting in a head error.The rotaflow console was functioning correctly, but the rotaflow drive has been found faulty.The affected rotaflow drive has been send back to germany for further investigations and repair at the manufacturer under rma# 42510.(b)(6)2020: the affected rotaflow drive was requested.(b)(6)2020: the rotaflow drive was received.(b)(6)2020: function test at the service department rastatt has been performed.Head error could be 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, instructions for use | 4.2 | en | 13, chapter 8.1.2 contain detailed descriptions to prevent an ¿error head¿.The reported failure "head error" occurred during the demo testing of the rotaflow.The device was directly involved in the incident and no able to meet ots specifications.The 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: 10724998
• MDR Text Key: 213006271
• Report Number: 8010762-2020-00352
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW
• Device Catalogue Number: 70104.3292
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1