BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 3113126 · Received May 9, 2013

    Report

    Report Number
    9615050-2013-01123
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 10, 2013
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 DEVICE DID NOT ALARM WHEN THE START BUTTON WAS NOT PRESSED. ON AN UNSPECIFIED DATE AND TIME, THE CUSTOMER CONTACT STATED THAT NURSE ATTEMPTED TO PROGRAM THE PRIMARY LINE OF THE DEVICE TO DELIVER AN UNSPECIFIED MEDICATION DURING AN UNSPECIFIED CONCURRENT DELIVERY. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT THE NURSE DID NOT PRESS THE START BUTTON AND AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THE DEVICE DID NOT ALARM N102 (INFUSER IDLE 2 MINUTES) AS EXPECTED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO, INCLUDING SPECIFIC EVENT DETAILS, PATIENT OUTCOME, AND IF ANY MEDICAL INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204971 PLUM A+ DRIVER ED 2 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK