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

Model Number CARDIOHELP

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a perfusionist who had patient on cardio-help got the "drive fan defective" message.He was advised her to get another unit ready to change out consoles.They changed consoles out without incident.Complaint number: (b)(4).

Manufacturer Narrative

Initially a "drive fan defective" message while use on patient was reported.According to the service order report (b)(4) (dated on 2020-10-26) the service technician was unable to replicate or find any problem.The device was tested and released for clinical use.Based on this the reported failure "drive fan defective" message could not be confirmed.This type of failure has been investigated in record#(b)(4).According to the investigation report (b)(4) (dated 2017-09-03) the most probable root cause is a temporary blocking of the fans by an accumulation of dust.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.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 number: (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: 10761774
• MDR Text Key: 213886882
• Report Number: 8010762-2020-00363
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

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: CARDIOHELP
• Device Catalogue Number: UNKNOWN
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1