MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HLS SET ADVANCED

Device Problem Unintended Movement (3026)

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

Event Date 05/19/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the error message ¿pump disposable error¿ was displayed.The failure occurred during priming.Switching the affected hls set to another cardiohelp did not solved the problem.The error message appeared again.A testing hls set did not showed the error message on both cardiohelps.Therefore the cardiohelp was excluded as the cause of the error message.The affected hls set could also not be used with the emergency drive.The centrifugal pump of the hls set is still not rotating.After multiple times of trying with the emergency drive and a significant use of force the emergency drive started to move on the hls set.No harm to any person has been reported.Complaint id# (b)(4).

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the error message ¿pump disposable error¿ was displayed.Switching the affected hls set to another cardiohelp did not solved the problem.The error message appeared again.A testing hls set did not showed the error message on both cardiohelps.Therefore the cardiohelp was excluded as the cause of the error message.The affected hls set could also not be used with the emergency drive.The centrifugal pump of the hls set is still not rotating.After multiple times of trying with the emergency drive and a significant use of force the emergency drive started to move on the hls set.A video was provided.The affected product was investigated by getinge laboratory on 2023-08-31 with following conclusion: the failure is not reproducible.However, according to the provided video of the customer the most probable root cause is a jamming of the rotor, which can cause the error message "pump disposable error".In the instruction of use (ifu) of the hls set advanced, in chapter ¿safety instructions for the oxygenator¿ it is stated to ensure that the device is fitted onto the drive correctly and securely fixed, to eliminate the risk of magnetic decoupling between the drive and the centrifugal pump and to not use the device if there is any failure during the priming procedure.The production records of the affected product were reviewed on 2023-08-31.According to the final test results, the modul passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "pump disposable error - pump not rotating" could not be reproduced but could be confirmed according to the provided video of the customer.This complaint was found in the database of customer complaints for the hls set as a single event (timeframe from 2022-05-22 till 2023-05-22).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.

• Brand Name: TUBING SET
• Type of Device: OXYGENATOR, 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: 17030784
• MDR Text Key: 316225590
• Report Number: 8010762-2023-00256
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112360
• 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: 09/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET ADVANCED
• Device Catalogue Number: 701069076
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1