BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL CITY CHILDREN ECC 1/4"

    MDR report key: 4093135 · Received August 21, 2014

    Report

    Report Number
    2248146-2014-00386
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    December 3, 2011
    Report Date
    December 4, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE NON-CONFORMITY REPORT, THE FLAW WAS EASILY CORRECTED ON-SITE, BUT DISCOVERED AT AN INOPPORTUNE TIME. THE CUSTOMER WAS CONTACTED REGARDING THE STATUS OF THE REMAINING FIELD INVENTORY AND STATED THAT THE KITS WERE USABLE AND DID NOT NEED TO BE REWORKED. THE CUSTOMER REQUESTED THAT THE REMAINING FINISHED GOODS INVENTORY BE INSPECTED AND REWORKED, IF NECESSARY, TO VERIFY THAT THE ISSUE WAS ISOLATED TO THE ONE UNIT AT THE HOSP. ALL ELEVEN KITS (7 KITS WITH LOT ID 13372-02 AND 4 KITS WITH LOT ID 13475-02) WERE PULLED FROM INVENTORY AND EVALUATED. ALL ELEVEN KITS WERE CONSIDERED ACCEPTABLE WITH NO ISSUES RELATED TO THE "BACKWARDS JOINT."BASED ON THE RESULTS OF THE EVAL, IT WAS DETERMINED THAT THE "BACKWARDS JOINT" WAS A RANDOM ONE-TIME OCCURRENCE THAT COULD BE ATTRIBUTED TO OPERATOR ERROR DURING THE JOINT ASSEMBLY PROCESS. MANUFACTURING PERSONNEL WERE RE-TRAINED TO THE CORRECT JOINT ASSEMBLY. ADDITIONALLY, THE NEXT LOT WILL BE 100% INSPECTED BY ADDITIONAL FLOOR PERSONNEL TO VERIFY THAT THE RE-TRAINING HAS BEEN EFFECTIVE AND THE ISSUES ARE NOT RECURRING. (B)(4).

    Description of Event or Problem · 1

    ONE FOURTH ECMO CIRCUIT TUBING SHOULD DETACH FROM THE OTHER SIDE FIGURED OUT WHILE EMERGENTLY PUTTING SOMEONE ONE. THE NEW CIRCUIT WE SET UP HAS SAME FLAW EASILY CORRECTED. CLOT AT ALL CONNECTOR SITES INCLUDING POST OXYGENATOR INFUSION LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506892 MEDICAL CITY CHILDREN ECC 1/4" CARDIOPULMONARY DEVICE DWE DATASCOPE CORP BEQ-T 21503 13265

    Patients

    Seq Age Sex Outcome Treatment
    1