BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1359675 · Received March 4, 2009

    Report

    Report Number
    2084725-2009-00124
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Date of Event
    February 2, 2009
    Report Date
    February 2, 2009
    Manufacturer
    UNITROL/MINNTECH COR
    Product Code
    NVE
    PMA / PMN Number
    K832458
    Removal / Correction Number
    Z-0281-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE CEC REPORTED THAT THE CUSTOMER WAS DISSATISFIED WITH THE STAINING OF THEIR CONNECTOR SETS AND DRIPPING. THE CEC MENTIONED THAT THIS IS USUAL FOR CIDEX OPA, BUT THE TUBING SETS EVEN AFTER TWO WEEKS OF USE WERE BLACK. THE CEC INSTRUCTED ON THE FOLLOWING: DILUTING THE ENZYMATIC TO THE PROPER CONCENTRATION WHEN WASHING SCOPES AND MAKING THE SINK SO AWARE OF HOW MANY PUMPS TO USE. THE CUSTOMERS ARE USING KLENZYME IN THE AER. THE CEC RECOMMENDED ENZOL. ALSO, THE CDC NOTICED THEY HAD A 6-MINUTE WASH CYCLE, CHANGED TO 1 MINUTE. THE CUSTOMER WAS ADVISED TO WATCH THE DRIPPING TO SEE IF IT IS ONLY FROM THE COLONOSCOPE OR THE GASTROSCOPE. THEY ARE USING THE MAJ 855 ATTACHMENT. ALSO, THE CEC ADVISED THAT THE BASINS SHOULD BE DRIED WITH A TOWEL AT THE END OF THE DAY AND LEFT OPEN. THE CEC NOTED THAT THE FACILITY IS AN EXCEPTIONALLY CLEAN DEPARTMENT. THE STAINING ON THE CONNECTOR SETS DID SEEM EXCESSIVE. AN ASP FIELD SERVICE ENGINEER (FSE) VISIT IS PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THERE WAS STAINING AND RESIDUE ON THE UNIT AND THEIR SCOPES. THE STAINING AND RESIDUE WERE IN ALL AREAS AFTER PROCESSING THE SCOPES IN THE UNIT WITH CIDEX OPA. THERE WERE NO REPORTS OF PHYSICAL COMPLAINTS. AN ASP CLINICAL EDUCATOR CONSULTANT (CEC) VISITED THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER AER EQUIPMENT NVE UNITROL/MINNTECH COR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CIDEX OPA