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

Model Number ROTAFLOW

Device Problem No Display/Image (1183)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

The initial failure description was that the rotaflow "display went black during patient treatment.The device was restarted and worked normally again.A getinge service technician was onsite on (b)(6) 2021.To test the affected rotaflow.The technician could not reproduce the reported failure after several start-ups.The rotaflow is working as intended.The rotaflow risk analysis version v06 chapter h1.1.1.34; h1.1.1.37 (dms# 2020689 was reviewed on (b)(6( 2021, with following most probable root cause: h1.1.1.37: malfunction of the microcomputer system: internal cpu failure non-volatile memory failure volatile memory failure in safety relevant variables watchdog failure time base failure on other device parts (rotary knob, display, etc) h1.1.1.34: display defects: wrong cleaning a device history review (dhr) was performed and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.Based on these investigation results the reported failure could not 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 patient treatment the display went blank.The customer restarted the rotaflow.After the restart, the device was working as intended again.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: 11441560
• MDR Text Key: 245318360
• Report Number: 8010762-2021-00156
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• 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: 701046405
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention