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 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the hl20 twin pump displayed the error message: "head".This error message can lead to a pump stop.No harm to any person has been reported.A getinge field service technician will be sent onsite for an investigation.As soon as new information becomes available, a follow up medwatch will be submitted.

Event Description

It was reported that the hl20 twin pump displayed the error message: "head".This error message can lead to a pump stop.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the hl 20 pump displayed the error message "head error" prior to use.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on (b)(6) 2023.The optical tacho board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The defective part was not available for further investigation.However the failure was already investigated in a similar complaint by the getinge life cycle engineering on 2019-08-26 with the following outcome.The most probable root cause could be determined as a broken wiring of the optical tacho board.Further the reported error message: "head" could be determined to the following most probable root cause according to the risk management file: (total) fail of device because of: defective tacho.The review of the non-conformities has been performed on 2023-11-15 for the period of (b)(6) 2014 to (b)(6) 2023.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 2014-11-04.Based on the results the reported failure "error head" could be confirmed.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: 17423355
• MDR Text Key: 320031596
• Report Number: 8010762-2023-00368
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2014
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1