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 Date 11/10/2023

Event Type  malfunction  

Event Description

It was reported that the hl20 got different error messages during treatment and the pump stopped two times.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the hl20 got different error messages during treatment and the pump stopped two times.No harm to any person has been reported.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.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the hl20 had different alarms going on during treatment and the pump stopped two times.No harm to any person has been reported.The customer was not able to provide any further information about any kind of alarms or any malfunction.A getinge field service technician was onsite for investigation on 2024 (b)(6).He could not reproduce the problem, no defects were detected.The customer informed the fst that the device was used further since (b)(6) 2023.No malfunction was reported.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.Thus the reported failure could not be confirmed.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: 18158876
• MDR Text Key: 328385707
• Report Number: 8010652-2023-00121
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/16/2024

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: 701043267
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1