BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1812791 · Received August 19, 2010

    Report

    Report Number
    2016493-2010-00459
    Event Type
    Other
    Date Received
    August 19, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 15, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 8/19/2010. (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. SERVICE LEVEL INVESTIGATION DETERMINED FLUID INGRESS CONTAMINATION; EVIDENCE OF STICKY FLUID WAS FOUND ON THE SIDE OF THE TOP OCCLUDER FINGER AND DRIED UP AND CRUSTED RESIDUE WAS FOUND ON THE CAMSHAFT RIBS AND GEAR TEETH. THE BEZEL ASSEMBLY WAS REPLACED AND THE DEVICE WAS RETURNED TO THE FACILITY AFTER PASSING ALL REQUIRED SERVICE LEVEL TESTING.

    Description of Event or Problem · 1

    CUSTOMER SENT DEVICE IN WITH REPORT OF RATE ACCURACY WAS DOUBLED DURING ROUTINE TESTING. THERE WAS NO PATIENT EVENT RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA