BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR

    MDR report key: 6641075 · Received June 14, 2017

    Report

    Report Number
    3012307300-2017-01255
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    May 12, 2017
    Report Date
    October 16, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ONE SAMPLE WAS RECEIVED FOR EVALUATION. BASED ON THE REPORTED INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE WHICH OF THE REPORTED POTENTIAL LOT NUMBERS WERE IMPACTED BY THE ALLEGED DEVICE DEFICIENCY. FUNCTIONAL TESTING WAS PERFORMED IN ORDER TO TEST FOR ANY POSSIBLE LEAKAGE. THE UNIT WAS PRESSURIZED TO 300MMHG. AFTER 24 HOURS, THE SAMPLE SHOULD HAVE RETAINED PRESSURE BETWEEN 300MMHG AND 150MMHG. THE SAMPLE DID NOT RETAIN THE REQUIRED PRESSURE. THIS COMPLAINT WAS CONFIRMED. THE ROOT CAUSE TO THE REPORTED ISSUE HAS BEEN ATTRIBUTED TO A SUPPLIED COMPONENT. AN IN-HOUSE 100 PERCENT LEAK TEST PERFORMED DURING MANUFACTURING HAD BEEN IMPLEMENTED AFTER THE REPORTED POTENTIAL LOTS WERE RELEASED FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    POTENTIAL LOT NUMBERS - 1375586, 2318203, 2520828,2641407, 2731314, 3031202, 3166207, 3277472, 3290524, 3330092, AND 3333628. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AIR LEAKED FROM A MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR, AND THE DEVICE DOES NOT HOLD PRESSURE. IT WAS ALSO NOTED THAT THERE WERE VISIBLE CRACKS ON THE "LIGHT BLUE PLASTIC PART". NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421524 MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR INFUSOR, PRESSURE, FOR I.V. BAGS KZD SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1