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 10/14/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the hl20 roller pump module displayed the error message "safety-s" during routine check.The error message: "safety-s" results in an unintentional pump stop.No patient was involved.No harm to any person has been reported.A getinge field service technician (fst) was onsite for an investigation of the device.The fst replaced the safety system board and the motor control board.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The replaced parts were requested for further investigation.As soon as new information becomes available a follow up medwatch will be submitted.

Event Description

It was reported that the hl20 roller pump module displayed the error message "safety-s" during routine check.The error message: "safety-s" results in an unintentional pump stop.No patient was involved.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 roller pump module displayed the error message "safety-s" during routine check.The error message: "safety-s" results in an unintentional pump stop.No patient was involved.No harm to any person has been reported.A getinge field service technician (fst) was onsite for an investigation of the device.The fst replaced the safety system board and the motor control board.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The replaced parts were not available for investigation.Thus no exact root cause could be determined for the reported failure.However a similar complaint was investigated at getinge life cycle engineering on 2023-06-19 and most probable root cause was identified as a loose contact in the connection cable to the control board.Further to this according to the hl20 risk assessment this event can be contributed to: wrong pump speed because of: - communication error (e.G.Wrong ratio between master-slave pumps due to communication error).The review of the non-conformities has been performed on 2023-10-06 for the period of 2013-10-07 to 2023-10-06.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 in question was manufactured on 2013-10-07.Based on the investigation results the reported failure "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.

• 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: 18018418
• MDR Text Key: 326679743
• Report Number: 8010762-2023-00528
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HL 20
• Device Catalogue Number: 701028580
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2013
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1