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

Model Number ROTAFLOW

Device Problem Battery Problem (2885)

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

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

The initial failure description was that the rotaflow has a "battery failure".The reported failure occurred during patient treatment and the device was directly involved in the event.A getinge service technician was onsite on (b)(6) 2021 to investigate the affected rotaflow.The 701017188 batterypack ni-cd 24v 132wh has been replaced.The battery was due in a month for replacement.In addition the rotaflow drive (serial number (b)(4)) has had a preventative maintenance.All functional tests were performed and the calibration validated.The device has been cleared for clinical use.The most probable root cause for the "battery failure" could be determined according to the service technician as the lifetime of the battery was due.As a new battery needed to be installed in (b)(6) 2021.According to the instruction for use (instructions for use | 4.2 | en | 13; 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 product in question was produced in 2015-07-27.The review of the non-conformities during the period of 2015-07-27 to 2021-01-28 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded.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

A battery failure occurred during patient treatment.The device has been exchanged.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
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 11243091
• MDR Text Key: 229402667
• Report Number: 8010762-2021-00089
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW
• Device Catalogue Number: 70105.1712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention