BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 2782152 · Received October 3, 2012

    Report

    Report Number
    2016493-2012-00433
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 7, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF THE INFUSION SYSTEM SMOKING WAS NOT REPLICATED BUT IT WAS CONFIRMED THAT THE SYSTEM EXPERIENCED A THERMAL EVENT. AN ON-SITE INSPECTION OF THE DEVICE IDENTIFIED THE PRESENCE OF A CRACK IN THE THERMALLY DAMAGED RIGHT IUI CONNECTOR ON THE PCU ALONG WITH EVIDENCE OF FLUID RESIDUE. A RESISTANCE MEASUREMENT ACROSS PINS 13 AND 14 FOUND THEM TO BE IN A SHORTED STATE WITH ALL OTHER ADJACENT PINS MEASURING AN OPEN CONDITION AS EXPECTED. IT IS BELIEVED BASED ON THE EVIDENCE THAT AN UNIDENTIFIED CONDUCTIVE FLUID CONTAMINATE ENTERED THE CRACK THAT CREATED A BRIDGE SHORT ACROSS PINS 13 AND 14 AND RESULTED IN THE THERMAL EVENT WITH THE IUI CONNECTOR. THE CAUSE FOR THE CRACK IN THE RIGHT IUI CONNECTOR IS UNKNOWN. THE LEFT IUI CONNECTOR ON THE PUMP MODULE WAS COLLATERALLY DAMAGED DUE TO ITS CONNECTION TO THE RIGHT IUI CONNECTOR OF THE PCU. THE RECEIVED LOGS HAD NO ENTRIES THAT THE INFUSION SYSTEM WAS USED ON THE REPORTED EVENT DATE ON SEPTEMBER 3, 2012. THE PCU WAS USED ON (B)(6)2012 WITH THE PUMP MODULE SN: (B)(4) BEING THE ONLY LOGGED DEVICE ATTACHED. THE RECEIVED LVP LOG WAS FROM SN: (B)(4) AND IT SHOWED ONLY BEING ATTACHED TO THE PCU ON (B)(6) 2012. THE PROXIMATE CAUSE FOR THE REPORTED ISSUE OF THE SYSTEM SMOKING IS BEING ATTRIBUTED TO THE THERMALLY DAMAGED RIGHT IUI CONNECTOR ON THE PCU. THE PROXIMATE CAUSE FOR THE THERMALLY DAMAGED RIGHT IUI CONNECTOR ON THE PUMP MODULE IS BEING ATTRIBUTED TO THE OBSERVED CRACK IN THE IUI CONNECTOR THAT COULD ALLOW A CONDUCTIVE FLUID CONTAMINATE TO ENTER THE CONNECTOR AND CREATE A BRIDGED SHORTED CONDITION BETWEEN THE PINS. THE ROOT CAUSE FOR THE OCCURRENCE OF THE CRACK IN THE RIGHT IUI CONNECTOR IS UNKNOWN AND NO MORE INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE HAD SMOKE AND A BURNING SMELL COMING FROM THE CHANNEL DURING A PATIENT INFUSION. A BRAIN (PCU) WITH TWO MODULES WAS IN USE ON A PATIENT IN INTERVENTIONAL RADIOLOGY. REPORTEDLY, THE RIGHT MODULE (CHANNEL B) BEGAN TO SMOKE AND A VERY STRONG BURNING ODOR WAS PRESENT. THE PUMP WAS REMOVED FROM USE AND SEQUESTERED IN CLINICAL ENGINEERING. NO PATIENT INJURY WAS REPORTED. EVENT OCCURRED AT (B)(6) HOSPITAL OF (B)(6). CUSTOMER STATED THAT NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PC UNIT FRN CAREFUSION CORP. 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other THERAPY DATE:| THERAPY DATE:| ALARIS ADMIN SET, MODEL/LOT UNK| ALARIS PUMP MODULE(S), SN (B)(4)