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

Model Number ROTAFLOW

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 during patient treatment the battery is not holding a charge.Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow "battery can not hold a charge".A getinge service technician was on site on 2021-07-05 to check the repair the affected rotaflow (serial#(b)(6)).The technician replaced the batterypack ni-cd 24v 132wh (rfc) (material#701017188).The device is working as intended.According to the technician the last battery replacement took place in 2019-07-29.Thus the most probable root cause could be determined that the lifetime of the battery was due as the battery needed to be replaced in july 2021.The product in question was produced in 2014-01-17.The review of the non-conformities has been performed on 2021-09-02 for the period of 2014-01-17 to 2021-07-01.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.Based on these investigation results the reported failure could be confirmed.In order to avoid reoccurrence of the reported failure, the user will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.3 | en | v14.Warnings in chapter 3.3.4 battery operation: check battery capacity every 6 months, at the latest.The battery must be replaced by the authorized technical service every 2 years, at the latest.The battery must be replaced sooner if it cannot be fully charged within 8.5 hours or if the system cannot be operated with the fully charged battery.The actual run time during battery operation depends on the age and condition of the batteries, current consumption of the rotaflow console and other factors.The run time shown is only a reference value.The actual run time can be shorter or longer.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.

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: 12164843
• MDR Text Key: 261446960
• Report Number: 8010762-2021-00389
• 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: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• 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: 701051697
• Date Manufacturer Received: 08/13/2021
• Patient Sequence Number: 1