BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITICOOL

    MDR report key: 16118897 · Received January 8, 2023

    Report

    Report Number
    1219702-2023-00008
    Event Type
    Malfunction
    Date Received
    January 8, 2023
    Date of Event
    October 14, 2022
    Report Date
    March 10, 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 S/N#220761 AND LOT# M220761, BELMONT SERVICE ENGINEERS CONFIRMED THE FAILURES BY USING LEAK TESTING, PERFORMED FUNCTIONAL TESTING FOR MAXIMUM USE TIME OF THE WRAPS, AND PERFORMED BURST TESTING. THE ROOT CAUSE WAS DETERMINED TO BE A CHANGE IN THE MANUFACTURING PROCESS OF THE WATER BARRIER AT A SUPPLIER OF THE MATERIAL. IF A LEAK OCCURS, THE PATIENT MAY GET WET, HOWEVER THERMOREGULATION WILL CONTINUE. IN THE EVENT THERMOREGULATION CANNOT CONTINUE DUE TO THE LEAK, THE DEVICE WILL ALARM TO ALERT THE USER. THE WRAP CAN BE REPLACED TO CONTINUE THERMOREGULATION. 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. THE FAILURES WERE ASSOCIATED WITH LOTS THAT WERE USING MATERIAL PRODUCED BY THE SUB SUPPLIER, WITH MODIFIED PROCESS PARAMETERS. BELMONT ISSUED A SCAR# SFN-2022-16 (SUPPLIER CORRECTIVE ACTION REQUEST) WAS ISSUED TO THE SUPPLIER (CREATIVE FOAM) NOVEMBER 9, 2022 TO THE SUPPLIER TO RESOLVE THIS ISSUE. THE FOLLOWING ACTIONS WERE TAKEN BY THE SUPPLIER: 1. INVESTIGATED INTERNAL MANUFACTURING PROCESSES UTILIZING SAMPLES PROVIDED BY CUSTOMERS AFTER FAILURE AND UNUSED PRODUCTS FROM LOTS THAT REPORTED A LEAK. THE INVESTIGATION FOCUSED ON THE WRAP SEALING PROCESS.THE INVESTIGATION RULED OUT HEAT SEALING OF THE WRAP AS THE ROOT CAUSE. 2. THE WATER BARRIER MATERIAL WAS SENT OUT FOR INVESTIGATION TO AN INDEPENDENT LABORATORY AND THE REPORT INDICATED A DIFFERENCE BETWEEN MATERIAL SUPPLIED PRIOR TO 2021 AND THE MATERIAL USED IN THE LISTED LOTS. 3. COMMUNICATION WITH SUB SUPPLIER OF THE WATER BARRIER MATERIAL CONCLUDED THAT THE SUB SUPPLIER INTRODUCED A VERY SLIGHT CHANGE TO THE MANUFACTURING PROCESS WHICH AFFECTED THE PROPERTIES OF THE MATERIAL, LEADING TO THINNER AREAS THAT HAD THE POTENTIAL TO LEAK. 4. THE SUPPLIER IMPLEMENTED A NO CHANGE AGREEMENT WITH THE SUB SUPPLIER TO ENSURE THAT NO CHANGES WITHOUT PRIOR APPROVAL WOULD BE INTRODUCED IN THE FUTURE AND THE SUB SUPPLIER RETURNED THE PROCESS TO THEIR ORIGINAL SPECIFICATIONS. ALL WRAPS ARE 100% LEAK TESTED BY PRESSURE DECAY TEST AT THE END OF THE MANUFACTURING PROCESS AND PRIOR TO PACKAGING. AN ADDITIONAL TESTING PERFORMING WET (DESTRUCTIVE) TEST WAS INTRODUCED AT THE SUPPLIER AS PART OF THE CORRECTIVE ACTION. BELMONT CONCLUDED THAT LOTS OF WRAPS MANUFACTURED WITH WATER BARRIER MATERIAL PRODUCED WITH THE MODIFIED PROCESS PARAMETERS COULD INCLUDE WRAPS WITH A WEAK MATERIAL AREA THAT POTENTIALLY COULD RESULT IN LEAKS DURING USE.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. WE RECEIVED THE CUREWRAP INVOLVED IN THIS INCIDENT BACK FOR INVESTIGATION ON NOVEMBER 16TH, 2022. BELMONT RECEIVED A MEDWATCH REPORT #(B)(4) ON DECEMBER 8TH, 2022. THE USER NOTICED LEAKING FROM CUREWRAP WHILE COOLING THE BABY FROM THE SAME LOT AS PREVIOUSLY REPORTED M220761 .THE PATIENT INVOLVED IN THE INCIDENT WAS NOT HARMED AS A RESULT OF THE INCIDENT. THE MEDWATCH REPORT #(B)(4) DETAILED THE PRODUCT PROBLEM THAT CUREWRAP INFANT COOLING BLANKET WAS FOUND TO BE LEAKING WHILE IN USE. THE PATIENT INVOLVED IN THE INCIDENT WAS UNHARMED SINCE THE WRAP WAS REPLACED. THE INVESTIGATION TO DATE HAS INDICATED THAT THE ISSUE WITH WRAP IS ATTRIBUTABLE TO A CHANGE IN THE COMPONENT MANUFACTURING PROCESS PARAMETERS BY OUR SUPPLIER'S SUB-SUPPLIER. BELMONT HAS ISSUED SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) TO THE SUPPLIER IN RELATION TO THIS ISSUE AND IS WORKING WITH THE MATERIAL TO ISSUE A PROCESS CHANGE AND ADDITIONAL TESTING TO AVOID ANY FURTHER ISSUES IN FUTURE. AS OF NOVEMBER 2022, THE SUB-SUPPLIER CONFIRMED THAT THEY REVERTED TO THE ORIGINAL PROCESS PARAMETERS AND THE MANUFACTURING PROCESS IS BACK IN CONTROL. WRAPS THAT BELMONT RECEIVED STARTING NOVEMBER 2022 WERE MANUFACTURED PER THE CORRECT MANUFACTURING PARAMETERS. ALL WRAP PRODUCTS MANUFACTURED DURING THE IDENTIFIED PERIOD OF THE MANUFACTURING PARAMETER CHANGE AND WITHIN THE CONTROL OF BELMONT, HAVE BEEN QUARANTINED. 6 LOTS HAVE BEEN FULLY CONSUMED. A REVIEW OF THE ASSOCIATED RISK MANAGEMENT HAS BEEN CONDUCTED AND IT HAS BEEN CONFIRMED THAT THE RISK INVOLVED IN THE INCIDENT IS LOW AND THE SEVERITY IS MINOR. 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. THE USER FACILITY REPORTED THAT THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. BELMONT IS CURRENTLY INVESTIGATING THE RETURNED CUREWRAP. WITHOUT RESULTS OF THE DEVICE INVESTIGATION, NO FINAL 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

    THE USER NOTICED LEAKING FROM CUREWRAP WHILE COOLING THE BABY FROM THE SAME LOT AS PREVIOUSLY REPORTED M220761 .THE PATIENT INVOLVED IN THE INCIDENT WAS NOT HARMED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565019 CRITICOOL THERMAL REGULATING SYSTEM DWJ BELMONT MEDICAL TECHNOLOGIES M220761 17290012127196

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown