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

Model Number HL 20

Device Problem Pumping Stopped (1503)

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

Event Date 11/18/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A getinge technician will investigate the hl 20.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that a hl 20 single head pump displayed the error message "error head".The customer change to another pump to continue treatment.The failure occurred during treatment.There were no harm to any person and no delays in treatment.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a hl 20 single head pump displayed the error message "error head".The customer change to another pump to continue treatment.The failure occurred during treatment.There were no harm to any person and no delays in treatment.The customer rejected the repairs and there was no service performed.However according to the getinge field service technician the most probable root cause was determined as a pump head motor failure.The review of the non-conformities has been performed on 2023-11-27 for the period of 2020-02-05 to 2023-11-19.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 2020-02-05.Based on the results the reported failure "error head" could be confirmed.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: 18217035
• MDR Text Key: 329129089
• Report Number: 8010762-2023-00590
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/05/2024

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: 701028580
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1