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

Model Number ROTAFLOW

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

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

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

The initial failure description was that the rotaflow displays the error message "head error".A getinge service technician repaired the affected rotaflow in the repair center on (b)(6) 2021.The technician replaced the 70101.1675 rfc (rotaflow console) power supply board.The device passed all tests and is working as intended.The 70101.7188 battery pack with fuse has been replaced as part of the 2 year preventative maintenance.The most probable root cause could be determined as the rotaflow drive with the serial number (b)(4) has bent pins which blew the fuse f4 on the power supply board.The product in question was produced in 2019-04-01 the review of the non-conformities has been performed on (b)(6) 2021 for the period of (b)(6) 2021 to (b)(6) 2024.It 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 a rotaflow displayed the error message ¿head error¿.No patient has been involved when the failure occurred.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): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 11768944
• MDR Text Key: 249760688
• Report Number: 8010762-2021-00282
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1