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

Model Number HL 20

Device Problem Failure to Pump (1502)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on 2023-05-19.The optical tacho board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the hl 20 pump displayed the error message "beltslip".No harm to any person was reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the hl 20 pump displayed the error message "beltslip".The failure occurred during routine checkup.No harm to any person was reported.A getinge field service technician (fst) was sent for investigation and repair on 2023-05-13 and 2023-05-19.The optical tacho board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.No exact root cause could be determined, because the defective optical tacho board was not available for further investigation at the manufacturer.A defective optical tacho board is a plausible cause for the error message "belt slip".Because the sensor no longer detects one or more lines on the film, it measures an apparently low speed at the pump head.Since this speed is then lower than the motor speed, the pump interprets this as a slipping belt and displays this message.The failure mode "belt slip" error message can also be linked to the following most possible root causes according to the hl 20 risk management file: -defective/ dirty tacho, relay or pump belt.The review of the non-conformities has been performed on 2023-05-16 for the period of 2015-11-04 to 2023-05-13.It 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 are unlikely.The device was manufactured on 2015-11-04.Based on the results the reported failure "error message "beltslip" could be confirmed.The device caused the complaint and was not able to work as per factory¿s specifications.The customer will be informed about the results by the getinge sales and service unit.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 id: (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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16972827
• MDR Text Key: 315643126
• Report Number: 8010762-2023-00228
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• 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: 701028580
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1