BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ TRIPLE NEW 8

    MDR report key: 1971710 · Received January 18, 2011

    Report

    Report Number
    9615050-2011-00031
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 20, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY MANDATORY MEDWATCH WAS RECEIVED ON 12/20/2010. THE REPORT NUMBER IS (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH RECEIVED THAT STATED: "PATIENT ON PHENYLEPHRINE IV DRIP. IV PUMP (B)(4) HAD E321 MALFUNCTION CODE- INTERRUPTING MEDICATION ADMINISTRATION. IV PUMP TAKEN OUT OF SERVICE FOR BIOMED TO EVALUATE." ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER CONTACT INCLUDING, SPECIFIC EVENT DETAILS, PATIENT INFORMATION, IF ANY MEDICAL INTERVENTIONS WERE REQUIRED, AND SPECIFIC PUMP PROGRAMMING. A RESPONSE HAS NOT YET BEEN RECEIVED. HOSPIRA IS CONTINUING TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ TRIPLE NEW 8 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK