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 Type  malfunction  

Event Description

It was reported that the hl20 pump displayed the error message: "safety-s" during testing.No harm to any person has been reported.This behaviour leads to an unintended pump stop.Complaint (b)(4).

Manufacturer Narrative

It was reported that the hl20 pump displayed the error message: "safety-s" during testing.No harm to any person has been reported.This behaviour leads to an unintended pump stop.A getinge field service technician will be sent onsite for investigation of the device.As soon as new information becomes available a follow up medwatch will be submitted.

Manufacturer Narrative

It was reported that the hl 20 pump displayed the error message "safety-s" during testing.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2023-08-22 and 2023-08-25.The fst could not replicate the error message: "safety-s" but error message: "beltslip" the optical tacho board was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the hl20 instruction for use 8.1.2 technical alarms the error message "beltslip" can occur when the pump speed is < 90% of the motor speed and does not result in a pump stop.The defective optical tacho board was not available for further investigation.However the reported error message: "beltslip" was assessed by the getinge life cycle engineering on 2019-11-11 with the following result: a defective optical tacho board is a plausible cause for the error message "belt slip".Because the sensor no longer detects one or more lines on the film, it measures an apparently low speed at the pump head.Since this speed is then lower than the motor speed, the pump interprets this as a slipping belt and displays this message.In addition the error message "beltslip" can also be linked to the following most possible root causes according to the hl 20 risk management file: -defective/ dirty tacho, relay or pump belt.Based on the results the reported failure "error message "beltslip" 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: 17622350
• MDR Text Key: 321928615
• Report Number: 8010762-2023-00421
• 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
• Report Date: 11/30/2023

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: 08/22/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2012
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1