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

Model Number ROTAFLOW

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

The initial failure description was that the rotaflow displays the error message " offset".The failure occurred during troubleshooting in the national repair center.A getinge service technician repaired the affected rotaflow serial number #(b)(4) on (b)(6) 2021.The technician confirmed the reported failure.The control board and power supply board were damaged while trouble shooting with them on another rotaflow unit.The 70101.1675 rfc (rotaflow console) power supply board and 70103.4051 rfc control board kit have been replaced.After the replacement, the device is working as intended again and passed all tests.A similar failure was already investigated by our life-cycle-engineering (lce) in complaint (b)(4) under the lce report (b)(4).Following root cause has been determined: a defect capacitor on the 70103.4051 rfc control board kit has caused a short circuit.The resulting strong increase in current in the + 12v circuit led to the triggering of fuse f2 on the 70101.1675 power supply board and the "offset error".The product in question was produced in 2013-10-22.The review of the non-conformities during the period of 2013-10-22 to 2021-02-22 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.Based on these investigation results the reported failure could be confirmed.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

It was reported that during preventative maintenance in the repair center the error message ¿offset error¿ was displayed.No patient has been involved.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: 11365814
• MDR Text Key: 233269757
• Report Number: 8010762-2021-00126
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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: 70104.3292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2013
• 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