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

Model Number MCP00706195#VARIO TWIN, HL 20, 4-PUMPS

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Head error was reported.Complaint #(b)(4).

Manufacturer Narrative

Head error was reported.The field service technician (fst) was sent for further investigation.According to service order #43525771 dated on 2020-12-17 tacho board was replaced with new one.Reseted both motor control, pump control pc connections,tested machine for 1 hour found it is working properly.Machine has been handed over to the customer in good working condition.A similar complaint (705009545) with the reported failure was already investigated.According to the life cycle engineering report# lce3993 dated on 2019-08-26 the most probable root cause is a broken wiring of the tachoboard.Thus the reported failure could be confirmed.The reported failure did not happen during patient treatment.The hl20 in question was responsible for this complaint/event.The review of the non-conformities during the period of 2016-03-09 to 2020-11-26 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.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 #(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: 10910562
• MDR Text Key: 219174701
• Report Number: 8010762-2020-00405
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706195#VARIO TWIN, HL 20, 4-PUMPS
• Device Catalogue Number: 701043262
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1