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

Model Number 701043292 - ROTAFLOW ENGLISH/US US-PLUG

Device Problem Battery Problem (2885)

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

Event Date 02/11/2020

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 an internal battery alarm was occurred on the rotaflow console.It is unknown when the incident occurred.Requested but still pending.No more details was provided.Also is it not clear which battery error occurred.Complaint id: (b)(4).

Manufacturer Narrative

The reported failure "battery alarm" occurred during preventive maintenance.According to the service order (b)(4) from the getinge field service technician dated on 2020-02-20 battery error message was hi tbmp, battery pack (701017188) was replaced on service at time of preventive maintenance as the battery has expired by time and was due to be replaced, there has been no problems sine the battery has been replaced.The most probable cause for the reported failure could be the life time of the battery has expired.The reported failure "battery alarm" occurred during preventive maintenance and could be confirmed.The device is 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: 9742672
• MDR Text Key: 200413612
• Report Number: 8010762-2020-00077
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701043292 - ROTAFLOW ENGLISH/US US-PLUG
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/31/2020
• Patient Sequence Number: 1