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 06/24/2022

Event Type  malfunction  

Event Description

It was reported that the hl20 device displayed the error message: "runaway".No harm to any person was reported.Reference number: (b)(4).

Manufacturer Narrative

It was reported that the hl20 device displayed the error message: "runaway".No harm to any person was reported.A getinge field service technician will be sent on site for investigation of the device.As soon as new information becomes available a follow up medwatch will be submitted.

Manufacturer Narrative

The event occurred in india.No harm to any person has been reported.It was reported that the hl20 device displayed the error message: "runaway" during pre use check performed by the customer.A getinge field service technician was onsite for investigation.The technician investigated the pump in question and found that the belts tension is loose.The technician suspected that the belts may be already due for replacement since the customer did not purchase the maintenance kit.After a replacement of the belts, the error message was not displayed again.The pump was handed over to the customer in good working condition.The belts were not available for further investigation nor were pictures available.However the reported failure could be linked to the following most probable root cause according to the hl20 risk management file (b)(4) v12: (total) fail of device because of: defective tacho, relay or pump belt.The device in question was manufactured on 2015-04-17.The review of the non-conformities during the period of 2015-04-17 to 2022-08-12 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.Thus the reported failure could be confirmed.The most probable root cause could be determined to belts which were overdue for replacement.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

Reference number: (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: 14883168
• MDR Text Key: 303303428
• Report Number: 8010762-2022-00258
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL 20
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2015
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose