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

Model Number ROTAFLOW

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

The initial failure description was that the rotaflow displays the error message "head error" during patient treatment no patient harm occurred.A getinge service technician was onsite on (b)(6) 2021 for repair of the affected rotaflow console with the serial number (b)(4).The technician found that the rotaflow drive (rfd) master socket to be loose.The rfd master socket has been readjusted and repositioned into the original position.The system is working as intended again and has passed all tests.The device has been returned for clinical use.The following most possible root cause could be determined for the head error: connection issues between the rota flow console and the drive can lead to a head error, for example loose rfd master socket.The review of the non conformities has been performed on 2021-03-25 for the period of (b)(6) 2009 to (b)(6) 2021.It does not show any nonconformity 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 product in question was produced in 2009-07-01.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 the rotaflow console causes the error message ¿head error¿.The device was restarted to clear the error message.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: 11568034
• MDR Text Key: 246489427
• Report Number: 8010762-2021-00213
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• 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: 701043291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention