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

Model Number CARDIOHELP-I

Device Problem Corroded (1131)

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

Event Date 10/31/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when additional information become available.A getinge service technician will investigate the cardiohelp.

Event Description

A unstable internal drive motor, intermittent loss of power, was reported.On the provided picture correded pins on the hls cable are shown.No indication of actual or potential for harm or death was reported.Information received that the customer used the emergency drive during treatment and changed the cardiohelp.Complaint number: (b)(4).

Manufacturer Narrative

It was reported that the drive motor was not stable and intermittent loss of power were observed.A getinge field service technician was sent for investigation and found deposits on the hls cable.The log files of the cardiohelp were analyzed by getinge, showing the error message ¿rpm control error¿.This message is caused by incorrect signals from the flow sensor, which could lead from a damaged sensor panel due to liquids.Customer was sent a quotation by getinge service department to replace the sensor panel and the connection cable for the disposable, however the customer decided not to repair the device and not replace the sensor panel and the connection cable.Since the sensor panel and the cable is not available for investigation the most probable root cause of the reported failure power loss can be linked to damaged sensor panel due to liquids.And the most probable root cause for the reported failure corroded pins hls cable can be linked to another investigation of a similar complaint which was conducted by getinge life cycle engineering: deposit were determined as wetting of the socket plane of the plug with salt-containing liquids (priming), which can cause the corroded pins.Based on this results results the reported failures "unstable internal drive motor, intermittent loss of power" and "corroded pins on hls cable" could 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.

Event Description

Complaintnumber: (b)(4).

• 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: 12778403
• MDR Text Key: 280516422
• Report Number: 8010762-2021-00588
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• 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: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 70 KG