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

Model Number ROLLER PUMP MODULE 20-SINGLE ROLLER PUMP

Device Problem Pumping Problem (3016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch will be submitted after new information has been received.

Event Description

It was stated that the hl20 pump displayed the error message "head error".(b)(4).

Event Description

Complaint: #(b)(4).

Manufacturer Narrative

It was stated that the hl20 pump displayed the error message "head error".The field service technician (fst) was sent for further investigation.According to service order # 43363441 dated on 2020-06-08 following works has been done: ran unit all night to check for error.Could not duplicate.Tested per service manual.All tests passed.2yr service, pm, calibration check, full functional test and safety check as per the service manual.All tests passed a similar complaint ((b)(4)) 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 "head error" could be confirmed.It is unknown when the event occurred, was the device being used for 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: 10117565
• MDR Text Key: 193972548
• Report Number: 8010762-2020-00186
• 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: 06/16/2020

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: ROLLER PUMP MODULE 20-SINGLE ROLLER PUMP
• Device Catalogue Number: 701027652
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/04/2020
• Patient Sequence Number: 1