BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2121173 · Received May 4, 2011

    Report

    Report Number
    9616066-2011-00159
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 4, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4), 2011. (B)(4). THE SET HAS BEEN RECEIVED, BUT THE INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER'S PATIENT SAFETY NET REPORT RECEIVED. STATED THAT A PATIENT REPORTED THAT AT END OF ZOMETA INFUSION, "IT WAS LEAKING A LITTLE". A WET SPOT WAS NOTED ON PATIENT'S SHIRT. AT THIS POINT INFUSION WAS ALREADY COMPLETE. SPIROS DEVICE CHECKED AND WAS CORRECTLY ACTIVATED ("SPINNING" ON END OF PRIMARY TUBING). TUBING TAKEN OFF PUMP AND HUNG TO GRAVITY AND NS COULD BE SEEN DRIPPING FROM WHERE PRIMARY TUBING CONNECTS TO SPIROS CONNECTOR PIECE, NOT FROM WHERE SPIROS CONNECTS TO MEDIPORT TUBING. TUBING AND ALL OTHER EQUIPMENT REMOVED. REPORT INDICATED THAT THERE MAY BE SOMETHING WRONG WITH THE SPIROS CONNECTOR. THERE WAS NO HARM REPORTED OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0500 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR THERAPY DATE:| SPIROS CONNECTOR| ALARIS PC UNIT, S/N UNK| ALARIS PUMP MODULE, S/N UNKNOWN| MEDIPORT, THERAPY DATE:| MEDIPORT TUBING, THERAPY DATE: