BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA PLS II

    MDR report key: 3182224 · Received June 14, 2013

    Report

    Report Number
    9615050-2013-01635
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 16, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K912928
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED DUE TO VIAL MANIPULATION. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER DILAUDID 1MG/ML AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2013, AT 2150, IT WAS REPORTED THE NURSE LOADED A NEW 30ML VIAL INTO THE DEVICE AND PRIOR TO STARTING THE DELIVERY, THE NURSE VISUALLY NOTED THERE WAS ONLY 19ML IN THE VIAL INSTEAD OF THE EXPECTED 30ML. AT THAT TIME, THE VIAL WAS IMMEDIATELY REMOVED FROM THE DEVICE AND THE PT WAS TREATED WITH AN UNSPECIFIED CONCENTRATION OF ROMAZICON. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT INDICATED THE ROMAZICON WAS THE INCORRECT REVERSAL AGENT FOR DILAUDID AND THE PT'S OXYGEN SATURATION DECREASE TO THE MID TO HIGH 80'S. NO SPECIFIC DETAILS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT'S OXYGEN SATURATION RETURNED TO AN UNSPECIFIED BASELINE. THE CUSTOMER CONTACT REPORTED THAT IT WAS UNSPECIFIED IF THE TUBING WAS CLAMPED PRIOR TO CHANGING THE VIAL. THE CUSTOMER CONTACT STATED THE MISSING 11ML OF DILAUDID COULD NOT BE ACCOUNTED FOR. AFTER AN UNSPECIFIED TIME, THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272057 PCA PLS II 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DILAUDID, MFR UNK