BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360

    MDR report key: 6659585 · Received June 22, 2017

    Report

    Report Number
    6659585
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    June 19, 2017
    Report Date
    June 20, 2017
    Manufacturer
    HOSPIRA INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA DEVICE MANUFACTURER'S STREET ADDRESS: (LINE 1) FOR TYPE OF DEVICE: INFUSION PUMP. CITY: FOR TYPE OF DEVICE: INFUSION PUMP. STATE: FOR TYPE OF DEVICE: INFUSION PUMP. ZIP: FOR TYPE OF DEVICE: INFUSION PUMP.

    Description of Event or Problem · 1

    15 IV PUMPS FAILED, 8 WITH BAD CONNECTIVITY ENGINE (CE) MODULE, AND THE REST WITH BAD MECHANISM. REQUESTING UNITS TO BE REPAIRED FOR THE LAST FEW MONTHS, HOSPIRA RESPONDED WITH NO PARTS AVAILABLE FOR THE REPAIR. ====================== MANUFACTURER RESPONSE FOR INFUSION PUMP, HOSPIRA (PER SITE REPORTER) ====================== PARTS NOT AVAILABLE.

    Description of Event or Problem · 1

    FIFTEEN IV PUMPS FAILED, 8 WITH BAD CONNECTIVITY ENGINE (CE) MODULE, AND THE REST WITH BAD MECHANISM. REQUESTING UNITS TO BE REPAIRED FOR THE LAST FEW MONTHS, HOSPIRA RESPONDED WITH NO PARTS AVAILABLE FOR THE REPAIR. MANUFACTURER RESPONSE FOR INFUSION PUMP, HOSPIRA (PER SITE REPORTER): PARTS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440603 PLUM 360 INFUSION PUMP FRN HOSPIRA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1