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

Model Number HL 20

Device Problem Pumping Problem (3016)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Heart lung machine hl20 displaying error message: "runaway".Reference number: (b)(4).

Manufacturer Narrative

Device was manufactured in 2008-04-25.The review of the non-conformities during the period of 2008-04-25 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.According to the service report#43529513 provided on 2021-01-22 the field service technician (fst) performed as follows: error diagnosis shows differences in the determination of the rounds per minute.Speed measurement adjusted using an oscilloscope set on the speedometer board.Motor carbon brush cleaned and belt tension checked.Test run and function check passed.The reported failure was "error message: runaway".The reported failure was already investigated in sap complaint #(b)(4).According to the investigation report (lce02505) the most probable root cause for the reported failure is an erroneous motor tacho generator signal due to the carbon brushes (e.G.Stuck carbon brush).The hl 20 instructions for use was also reviewed on 2020-11-23 with the following outcome: extreme and sudden changes in the flow rate, especially during pulsatile pumping can also lead to a "run away" alarm.The reported failure "error message: runaway" could be confirmed.The reported failure "error message: runaway" 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.

Event Description

Reference 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: 10957699
• MDR Text Key: 219885462
• Report Number: 8010762-2020-00420
• 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: 01/26/2021

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: 70101.0825
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1