BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PC UNIT

    MDR report key: 1973085 · Received January 19, 2011

    Report

    Report Number
    2016493-2011-00206
    Event Type
    Other
    Date Received
    January 19, 2011
    Date of Event
    October 1, 2010
    Report Date
    October 19, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2011. (B)(4). PRODUCT EVALUATED, DEVICE EVENT LOGS REVIEWED AND THE REPORT THAT THE PC UNIT SMOKED WHEN PLUGGED IN WAS NOT CONFIRMED. HOWEVER, BURNT PINS ON THE RIGHT IUI CONNECTOR AND CORROSION ALONG THE BOTTOM OF THE POWER SUPPLY BOARD WERE CONFIRMED. THE ROOT CAUSE WAS NOT IDENTIFIED BUT THE BURNT PINS ON THE RIGHT IUI CONNECTOR WERE CONSISTENT WITH FLUID EXPOSURE. THE REPORTED ERROR CODE 133.6100 WAS CONFIRMED FROM THE DEVICE EVENT LOGS. THE ROOT CAUSE OF THE ERROR CODE WAS MOST LIKELY DUE TO THE BATTERY VOLTAGE BEING COMPLETELY DISCHARGED. ONCE THE BATTERY WAS FULLY CHARGED, THERE WAS NO FURTHER OCCURRENCE OF THE ERROR CODE. THE REPORT OF THE TWO ASSOCIATED PUMP MODULES NOT BEING RECOGNIZED BY THE PC UNIT WAS CONFIRMED. THE ROOT CAUSE WAS IDENTIFIED AS DAMAGE TO THE FEMALE IUI CONNECTOR ON EACH OF THE RESPECTIVE PUMP MODULES. DAMAGE TO THE IUI CONNECTOR ON PUMP MODULE SN (B)(4) WAS CONSISTENT WITH AN ELECTRICAL SHORT FROM FLUID EXPOSURE. DEVICE MFR DATE: 01/2009. DAMAGE TO THE IUI CONNECTOR ON PUMP MODULE LVP SN (B)(4) WAS CONSISTENT WITH FOREIGN MATERIAL BEHIND ONE OF THE CONNECTOR PINS. DEVICE MFR DATE: 01/2009.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARIS PC UNIT SMOKED WHEN PLUGGED IN. CUSTOMER STATED DOES NOT KNOW IF THE DEVICES WERE ON A PT AT THE TIME. ADDITIONALLY, REPORTED ERROR CODE 133.6100 AND THE TWO PUMP MODULES THAT WERE ATTACHED TO THE PC UNIT AT THE TIME, WERE NOT RECOGNIZED BY THE PC UNIT OR ANY OTHER PC UNIT. NO PT OR STAFF HARM REPORTED. ALTHOUGH REQUESTED, NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PC UNIT FRN CAREFUSION CORP. 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE, (B)(4)| ALARIS PUMP MODULE, (B)(4)