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

Model Number CARDIOHELP-I

Device Problem Overheating of Device (1437)

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

Event Date 11/02/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

A sensor panel replacement due to fan errors was reported.Further information received on 2022-11-08 that error message "ventilation error" was displayed on the cardiohelp.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair on 2022-11-16 and 2022-11-30.The fans were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow up will submitted when additional information become available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

Initially a sensor panel replacement due to a fan error was reported.The failure was detected during preventive maintenance by getinge field service technician (fst).The fst confirmed the error message ¿defective fan¿ and replaced the fan as well as the sensor board.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the provided log files the reported failure ¿defective fan¿ could not be confirmed on the reported date of event.The log files of the reported date of event was not provided.The replaced fan was returned to manufacturer for further investigation and was investigated by getinge life-cycle-engineering.The root cause was found to be a probable manufacturing defect of the fan at the corner, which had a crack.Thus, the complaint information was transferred to internal non conformity team.Based on the results the reported failure "fan errors" 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.This complaint cause was found as a single event in the data system for the reviewed period.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: 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: 15767852
• MDR Text Key: 304344661
• Report Number: 8010762-2022-00445
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133598
• 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,Followup,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• 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: 09/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1