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 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on (b)(6) 2023.The motor control board 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 (b)(6) 2023 for the period of 2(b)(6) 2013 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 2013-10-23.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in portugal during start up.It was reported that the hl20 pump ran quickly when starting and then stopped displaying the error message: ¿runaway¿.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 hl20 pump ran quickly when starting and then stopped displaying the error message: ¿runaway¿.The failure occurred during start up.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 motor control board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The affected motor control board (article number (b)(4)) was requested for return for further investigation at getinge life cycle engineering.As confirmed by the field service technician on (b)(6) 2024 the affected motor control board is no longer traceable during transport to the manufacturer.Therefore no technical investigation of the defective part could be performed.However the reported error message: "runaway" can be linked to the following most possible root cause according to the hl20 risk management file: wrong pump speed because of: - communication error (e.G.Wrong ratio between master-slave pumps due to communication error) - pump runaway - pump blocked if significant information, regarding the availability of the defective part is received the complaint will be reopened and necessary steps will be initiated.The review of the non-conformities has been performed on (b)(6) 2023 for the period of (b)(6) 2013 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 (b)(6) 2013.Based on the results the reported failure "runaway error message" 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.

• 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: 17824673
• MDR Text Key: 324352496
• Report Number: 8010762-2023-00479
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 02/01/2024

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: 701047032
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1