BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 12907341 · Received December 1, 2021

    Report

    Report Number
    8010762-2021-00630
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 30, 2021
    Report Date
    January 26, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FAILURE OF THE CARDIOHELP WAS REPORTED: ¿PVEN TO NEGATIVE ¿ DELTA P TOO HIGH¿. THE CARDIOHELP WAS EXCHANGED DURING TREATMENT. THE RELATED HLS SET WAS NOT AVAILABLE FOR INVESTIGATION. A GETINGE SERVICE TECHNICIAN WAS SENT FOR INVESTIGATION OF THE CARDIOHELP UNIT ON 2021-11-30. HE COULD CONFIRM, THAT THE CONNECTION CABLE FOR DISPOSABLES (HLS CABLE) WAS NOT SECURED TO THE BACK PANEL. SERVICE TIGHTEN THE COLLAR OF THE CONNECTOR AND STABILIZED THE READINGS. THIS SOLVED THE ISSUE. THE UNIT WAS TESTED AND PUT BACK IN USE. THE LOG FILES OF THE CARDIOHELP WERE ANALYSED BY GETINGE EXPERTS. NO PRESSURE RELATED ERROR COULD BE CONFIRMED. IT WAS SEEN THAT THE HLS CABLE WAS DISCONNECTED MULTIPLE TIMES MOST PROBABLE BY AN INSUFFICIENT CONNECTION DUE TO THE LOOSE CONNECTOR. AS CONFIRMED BY THE GETINGE TECHNICIAN THE ROOT CAUSE WAS IDENTIFIED AS AN INSUFFICIENT CONNECTION OF THE HLS CABLE LEADING TO INCORRECT PRESSURE VALUES. THIS RELATION WAS ALREADY IDENTIFIED IN THE CARDIOHELP RISK ANALYSIS V23 (DMS# 2021972): - WRONG PLUGGED PRESSURE SENSOR OR DISCONNECTION (MIX UP). BASED ON THIS RESULTS THE REPORTED FAILURE "¿PVEN TO NEGATIVE ¿ DELTA P TOO HIGH¿ 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.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WILL BE SUBMITTED, WHEN ADDITIONAL INFORMATION BECOME AVAILABLE. A GETINGE SERVICE TECHNICIAN WAS ON SITE AND FOUND LOOSE CONNECTOR ON THE SENSOR PANEL. THE UNIT WAS REPAIRED AND PUT BACK IN USE. DEEPER INVESTIGATION AND ROOT CAUSE ANALYSES IS STILL ONGOING.

    Description of Event or Problem · 0

    COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED: ¿PVEN TO NEGATIVE ¿ DELTA P TOO HIGH¿. THE CARDIOHELP WAS SWAPPED WITH A BACKUP SYSTEM. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809133 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown