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 Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Hl20 has damaged wheels and error message: "s-stop" was shown.Reference number: (b)(4).

Event Description

Reference number: (b)(4).

Manufacturer Narrative

The product in question was produced in 2012-03-20.The review of the non-conformities during the period of 2012-03-20 to 2020-12-17 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#3156006417 the field service technician performed the following investigation: he replaced two hl20 rotation wheels total lock and the safety system board.After that, the device was full functional again.The reported failure was "damaged wheel and error message: s-stop".According to the service report#3156006417 the field service technician performed the following investigation: he replaced two hl20 rotation wheels total lock for the damaged wheel and the safety system board for the error message s-stop.After replacement and functional checks the device was full functional as intended.The device was not returned for investigation in the lab as this was already investigated in a similar complaint id#complaint #(b)(4)& (b)(4)with the following outcome: the device was powered by a hl20 machine with a power-supply-only extension cable.The service terminal was monitored.Upon startup, the pump head ran at maximum speed in the counter clock direction, an alarm was triggered and the error message ¿err.S-stop¿ was displayed.In the service terminal report the safety-stop test was registered as failed; therefore, the startup routine wasn¿t completed successfully.Control signals and the 24v voltage supply line deviated from the expected behavior.The transistor t1 was found to be defective and exchanged with a functioning one.The dut was tested again; the device completed startup routine successfully.The 24v voltage line and involved control signals behaved as expected.The cause of this damage can be related to a voltage transient or a statistical failure.Thus the reported failure "error message: s-stop" could be confirmed.The most probable root cause of the error message s-stop is a defective power mosfet (transistor t1).The cause of this damage can be related to a voltage transient or a statistical failure.The reported failure "damaged wheel could be confirmed and most probable root cause could be determined to aging or rough handling.We have not been informed about the time of instance when the failures defective wheel and error message: s-stop occured.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: 10768725
• MDR Text Key: 214140009
• Report Number: 8010762-2020-00366
• 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: 12/24/2020

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: HL 20
• Device Catalogue Number: MCP0.0706189
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1