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 08/30/2023

Event Type  malfunction  

Event Description

It was reported that the hl20 arterial pump displayed the error message ¿direct¿.Later during inspection also the errors ¿beltslip¿ and ¿safety-s¿ were reported.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on 2023-08-30.The optical tacho kit was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The review of the non-conformities has been performed on 2023-09-14 for the period of 2018-05-15 to 2023-08-30.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 2018-05-15.A follow-up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that the hl20 arterial pump displayed the error message ¿direct¿.The event occurred during a routine check.Later during inspection also the errors ¿beltslip¿ and ¿safety-s¿ were reported.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2023-08-30.The optical tacho board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The defective optical tacho board was not available for further investigation.The reported failure was assessed by the getinge life cycle engineering on 2024-01-10.The most probable root cause for all three error messages "direct", ¿beltslip¿ and ¿safety-s¿ was determined as a defect optical transceiver on the optical tacho board.The review of the non-conformities has been performed on 2023-09-14 for the period of 2018-05-15 to 2023-08-30.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 2018-05-15.Based on the results the reported failure "error message "direct", ¿beltslip¿ and ¿safety-s¿" 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: 17743486
• MDR Text Key: 323361424
• Report Number: 8010762-2023-00462
• 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: 01/15/2024

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: 701043262
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1