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

Model Number HL 20

Device Problems Pumping Stopped (1503); Pumping Problem (3016)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

It was reported that the hl20 pump intermittently displayed the error message: "runaway".No harm to any person was reported.The error message: "runaway" can result in an unintentional pump stop, therefore a report is required.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the hl20 pump intermittently displayed the error message: "runaway".No harm to any person was reported.The error message: "runaway" can result in an unintentional pump stop, therefore a report is required.A getinge field service technician will be sent for investigation and repair of the device.As soon as new information becomes available a follow-up medwatch will be submitted.

Manufacturer Narrative

It was reported that the hl20 roller pump module displayed the error messages: ¿runaway¿ intermittently.The event occurred during a routine check.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2024-01-05.The belt was replaced.The tacho strobe foil and board were cleaned and all connections of the pump were reset.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.As confirmed by the getinge field service technician the belt which caused the failure was over its service life of 12 months and there were already visible signs of damage on the belt.Therefore the root cause was determined as overdue replacement of a wearing part.According to the hl 20 instruction for use chapter 10 maintenance the user is instructed to get the hl20 inspected by the authorized service every 12 months.In the service manual chapter 4.2 "replacement of belts on rpm" it is noted that the belts have to be inspected and if found twisted, have wear, cracking, or service life over 12 months they must be replaced.The review of the non-conformities has been performed on 2024-03-25 for the period of 2016-04-22 to 2023-12-13.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 2016-04-22.Based on the results the reported failure "runaway¿ intermittently" 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).

Manufacturer Narrative

The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on (b)(6) 2024.The belt was replaced.The tacho strobe foil and board were cleaned and all connections of the pump were reset.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 2024-03-25 for the period of (b)(6) 2016 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 2016-04-22.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the hl20 roller pump module displayed the error messages: ¿runaway¿ intermittently.The event occurred during a routine check.No harm to any person has been reported.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: 18370717
• MDR Text Key: 331053207
• Report Number: 8010762-2023-00637
• 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,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2024

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: 70102.8580
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 03/25/2024; 04/04/2024
• Supplement Dates FDA Received: 03/25/2024; 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1