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 Type  malfunction  

Manufacturer Narrative

It was reported that the error message "safety-s" was displayed on a hl20 pump.The event occurred during routine check.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2023-11-29.The pump was checked, restarted and the connections inside the pump were reset.The failure could not be replicated and no parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the getinge field service engineer the issue was solved by restarting and resetting all connections inside the pump, since then the error message was not displayed again.The most probable root cause was that the position of the pump head was unknown.With reference to the hl20 risk assessment (risk id: h1.1.1.2.7) this event can be also contributed to: wrong pump speed because of: wrong ratio between master-slave pumps due to communication error.The review of the non-conformities has been performed on 2023-11-30 for the period of 2018-05-15 to 2023-11-29.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 2018-05-15.Based on the results the reported failure " error message safety-s" could not 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

It was reported that the hl20 pump displayed the error message: safety-s which leads to a pump stop.The event occured during routine testing.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: 18272913
• MDR Text Key: 329809969
• Report Number: 8010762-2023-00603
• 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
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• 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: 701043262
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2019
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1