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

Model Number HL 20

Device Problem Pumping Stopped (1503)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Error message: "belt slip" was displayed on a hl20 heart lung machine.

Event Description

Reference number: (b)(4).

Manufacturer Narrative

Device was manufactured in 2008-05-01.The review of the non-conformities during the period of 2008-05-01 to 2020-11-15 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.According to the ssu the field service technician (fst) performed as follows: the pump was checked by the fst.The fst reconnected the belt kit.After that the pump worked again.Pump was handed over to customer in good working condition.The reported failure was "error message: belt slip." the most probable root cause could be determined to a wrong tension of the belts.The reported failure "error message: belt slip" could be confirmed.The reported failure "error message: belt slip" did not happen during patient treatment.The hl20 in question was responsible for this complaint event.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.

• 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: 10913921
• MDR Text Key: 218522815
• Report Number: 8010762-2020-00410
• 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: 01/22/2021

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: HL 20
• Device Catalogue Number: 7010.28697UL
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1