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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the hl 20 unit displayed "belt slip" error message during checking of the machine.No harm to any person was reported.A getinge field service technician (fst) was onsite and investigated the unit in question on 2022-07-16.The problem was resolved by replacing the optical tacho board.The system was checked according to factory¿s specification and all tests passed.The device was put back into use.Thus the reported failure "error message: beltslip" could be confirmed.The affected optical tacho board was not returned for further investigation, therefore no technical investigation could be performed.However the failure mode "belt slip" error message can be linked to the following most possible root causes according to the hl 20 risk management file: -defective/ dirty tacho, relay or pump belt a dirty foil or 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.Device was manufactured in 2016-03-30.The review of the non-conformities during the period of (b)(6) 2016 to (b)(6) 2016 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 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

It was reported that the hl 20 unit displayed "belt slip" error message during checking of the machine.No harm to any person reported.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: 15119348
• MDR Text Key: 304801141
• Report Number: 8010762-2022-00285
• 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,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 701043262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose