MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP-I

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Event Description

It was reported that the rotary flow control was dysfunctional.The rmp would increase instead of decreasing.No harm to any person has been reported.Complaint id # (b)(4).

Manufacturer Narrative

A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id # (b)(4).

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation.The rotary encoder was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow-up medwatch will be submitted when additional information becomes available.

• Brand Name: CARDIOHELP
• 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: 18561530
• MDR Text Key: 333447697
• Report Number: 8010762-2024-00035
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1