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

Model Number ROTAFLOW ENGLISH/US US-PLUG ICU

Device Problem Premature Discharge of Battery (1057)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.Further information has been requested but has not yet been received.

Event Description

It was reported that the battery of the rotaflow died during the patient treatment.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow " battery turned off during patient treatment".A getinge service technician was on site on 2021-09-27 to repair the affected rotaflow console (rfc) (serial(b)(6)).The technician started that rotaflow in the battery mode and the voltage of the battery was 25.8v.Therefore, the battery was within tolerance.Therefore, the technician could not confirm the reported failure.Neverless, the technician replaced the batterypack ni-cd 24v 132wh (material#701017188) as the rotaflow was due for preventative maintenance in novemeber 2021.After the replacement the device is working as intended.Based on these investigation results the reported failure could not be confirmed.However the failure mode " battery turned off during patient treatment" can be linked to the following most possible root causes according to our risk management file (dms# 2023689).Battery power failure e.G.: defect batteries, power supply board failure, software error, user forgot recharge, defect of charger unit.The product in question was produced in 2012-05-01.The review of the non-conformities has been performed on 2021-10-14 for the period of 2012-05-01 to 2021-09-16.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.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.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.

• 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: 12512401
• MDR Text Key: 272677721
• Report Number: 8010762-2021-00515
• 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: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW ENGLISH/US US-PLUG ICU
• Device Catalogue Number: 701051712
• Date Manufacturer Received: 09/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention