MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number MCP00703157#RFC 20-970 ROTAFLOW CONSOLE

Device Problem Temperature Problem (3022)

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

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

It was reported from a customer from (b)(6) that temp err¿ was displayed on the rota flow console in-use.Continue to replace with an alternative machine.No harm to the patient was reported.(b)(4).

Manufacturer Narrative

Maquet field service technician was in onside to investigate the device in question on 2019-10-24.The affected rotaflow console with serial number (b)(6) was checked and the failure could not be reproduced.Technician is thinking of a preventive exchange of the control board because it doesn't reproduce.If the board is exchanged is requested but after several requests no information provided.Thus the reported failure could not be confirmed.No probable root cause could be determine because no failure detected.The occurence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.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.

Event Description

Complaint id: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9178354
• MDR Text Key: 192162135
• Report Number: 8010762-2019-00318
• Device Sequence Number: 1
• Product Code: DTQ
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703157#RFC 20-970 ROTAFLOW CONSOLE
• Device Catalogue Number: 701028716
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/24/2019
• Patient Sequence Number: 1