BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITICOOL

    MDR report key: 15898801 · Received December 1, 2022

    Report

    Report Number
    1219702-2022-00044
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    October 20, 2022
    Report Date
    January 30, 2023
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    DWJ
    UDI-DI
    17290012127196
    PMA / PMN Number
    K083662
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THE REFERENCED CUREWRAP, HAVING LOT# M220761 & LOT# M222131, SERVICE ENGINEERS FOUND THAT LEAKS COULD BE VERIFIED FROM THE FABRIC OF THE WRAP IN EACH OF THE RETURNED SAMPLES. INVESTIGATION IDENTIFIED THE WATER BARRIER FILM AS THE CAUSE FOR THE LEAKS. THE ROOT CAUSE WAS DETERMINED TO BE A CHANGE IN THE MANUFACTURING PROCESS OF THE WATER BARRIER AT A SUPPLIER OF THE MATERIAL. THE CHANGE LED TO UNFAVORABLE PROPERTIES OF THE MATERIAL AND A POTENTIAL OF THE MATERIAL HAVING MICROSCOPIC PINHOLES THAT WERE NOT DETECTABLE DURING THE MANUFACTURING AND TESTING PROCESS. THE LOTS INVOLVED IN THE REPORTED COMPLAINTS WERE DETERMINED TO HAVE BEEN MANUFACTURED WITH THIS COMPROMISED MATERIAL. BELMONT ISSUED A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) TO THE SUPPLIER TO RESOLVE THIS ISSUE. AS OF NOVEMBER 2022, THE PROCESS WAS CORRECTED TO THE ORIGINAL PROCESS PARAMETERS AND THE MANUFACTURING PROCESS WAS BROUGHT BACK UNDER CONTROL. WRAPS THAT BELMONT RECEIVED STARTING NOVEMBER 2022 WERE MANUFACTURED WITH CORRECTED WATER BARRIER MATERIAL AND THOSE WRAPS HAVE BEEN PROVIDED TO REPLACE THE DEFECTIVE WRAPS. BELMONT VISITED THE USER FACILITY ON DEC 19TH 2022 TO GATHER ADDITIONAL INFORMATION AND ENSURE THAT THE REPLACED WRAPS ARE WORKING AS INTENDED WITHOUT ANY ISSUES. UPON DISCUSSION WITH THE CLINICAL STAFF, THEY CONFIRMED THAT THE NEWLY SENT WRAPS ARE WORKING WITHOUT ANY PROBLEMS. WE WILL CONTINUE TO MONITOR THIS TYPE OF INCIDENT AND TAKE FURTHER CORRECTIVE AND PREVENTIVE ACTIONS IF REQUIRED.

    Additional Manufacturer Narrative · 0

    THE INTERNAL COMPLAINT FILE # (B)(4) HAS BEEN LOGGED FOR THIS INCIDENT FOR TRACEABILITY. BELMONT RECEIVED THE CUREWRAP BACK FOR INVESTIGATION ON 10/21/2022 HOWEVER, THE CRITICOOL AND CLINILOGGER WERE NOT SENT BACK. THE RISK MANAGER REPORTED THAT COOLING BLANKET (CUREWRAP) FAILED DURING THERAPEUTIC COOLING OF A NEONATE. NO CHANGE IN PATIENT'S TEMPERATURE. ABLE TO BE REPLACED. THE WRAP INVOLVED IN THE INCIDENT WAS REPLACED BY ANOTHER CUREWRAP TO COMPLETE THE PROCEDURE ON CHILD. THE WRAP COULD HAVE FAILED TO COOL THE PATIENT BECAUSE OF THE FOLDS AT THE TIME OF INSTALLATION WHICH MAY RESULT INTO INSUFFICIENT WATER FLOW. THE OPERATOR'S MANUAL INFORMS THE USER, "IF MOISTURE OR LEAKS ARE DISCOVERED IN THE CONNECTING HOSE AND/OR WRAP, TURN OFF THE CRITICOOL DEVICE, DISCONNECT THE POWER CABLE FROM ITS POWER SOURCE, AND CORRECT THE PROBLEM BEFORE PROCEEDING." THE MANUAL ALSO PROVIDES A TROUBLESHOOTING GUIDE FOR WATER LEAKS, AS WELL AS THE FOLLOWING WARNING STATEMENT: "WATER MAY DRIP FROM THE INLET TUBES OF THE WRAPS. BE SURE THAT NO ELECTRICAL DEVICE OR OUTLET IS LOCATED UNDER THE CRITICOOL'S WATER INLET OR WRAP TUBES. WHEN DISCONNECTING WRAPS FROM THE CRITICOOL CONFIRM THAT THE CLAMPS ARE TIGHT, TO PREVENT WATER LEAKING FROM THE WRAP."ALL CUREWRAPS ARE 100% LEAK TESTED BY THE MANUFACTURER PRIOR TO RELEASE FOR SHIPMENT. NO PATIENT INJURY WAS REPORTED. THERE IS NO INDICATION OF PATIENT HARM AS A RESULT OF THE REPORTED INCIDENT. THE USER REPORTED THAT THERE WERE NO CLINICAL CONSEQUENCES FOR THE CHILD. A REVIEW OF PAST COMPLAINTS INDICATES THAT THIS WAS AN ISOLATED INCIDENT. WITHOUT HAVING THE UNIT OR CLINILOGGER BACK FOR INVESTIGATION IT IS DIFFICULT TO DETERMINE WHETHER THE UNIT MALFUNCTIONED OR NOT.BELMONT IS CURRENTLY INVESTIGATING THE RETURNED CUREWRAP. WITHOUT RESULTS OF THE DEVICE INVESTIGATION, NO CONCLUSIONS CAN BE DRAWN. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COOLING BLANKET FAILED DURING THERAPEUTIC COOLING OF A NEONATE. NO CHANGE IN PATIENT'S TEMPERATURE. ABLE TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2525894 CRITICOOL THERMAL REGULATING SYSTEM DWJ BELMONT MEDICAL TECHNOLOGIES 220761 17290012127196

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown