BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3133936 · Received May 1, 2013

    Report

    Report Number
    9616066-2013-00258
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP MODULE LOGS INVOLVED IN THIS EVENT WAS PREVIOUSLY EVALUATED AND IT IS BELIEVED THE PUMP MODULE PERFORMED AS PROGRAMMED (REFERENCE MFR REPORT 2016493-2013-00138). THE SET WAS THEN REC'D AND THE RESULTS ARE AS FOLLOWS: THE CUSTOMER'S REPORT OF AN OVER INFUSION OF FENTANYL WAS NOT CONFIRMED. VISUAL AND FUNCTIONAL TESTING NOTED A (0.00734' X 0.01699') HOLE IN THE PROXIMAL SMARTSITE PORT. THERE WERE ALSO HESITATION MARKS SURROUNDING THE HOLE. THE HOLE RESEMBLES THE APPEARANCE OF A NEEDLE PUNCTURE. THE ROOT CAUSE OF THE LEAK WAS A HOLE IN THE PROXIMAL SMARTSITE PORT.

    Description of Event or Problem · 1

    BIOMED REPORTED THAT A MEDICATION WAS DELIVERED FASTER THAN IT WAS PROGRAMMED. THE NURSE HAD HUNG A 90 ML BAG OF FENTANYL TO BE INFUSED AT 13.86 ML PER HOUR VIA A PRIMARY INFUSION. THE FENTANYL INFUSION RATE WAS CHECKED BY ANOTHER NURSE. THE RATE HAD BEEN INCREASED FROM 10 ML TO 13.86 ML PER HOUR SOME TIME DURING THE NIGHT. IT WAS REPORTED THAT THE PT EXPERIENCED HYPOTENSION AT 06:25 AM. THE HYPOTENSION BECAME MORE SEVERE WHEN THE PT WAS TURNED (NO VALUES PROVIDED). AT 6:40 AM THE DEVICE WAS ALARMING FOR AIR IN LINE AND ALL THE FENTANYL HAD INFUSED. THE NURSE BELIEVED THE HYPOTENSION WAS RELATED TO RECEIVING TOO MUCH FENTANYL. THE NURSE STOPPED THE INFUSION AND DISCONNECTED THE TUBING AND THE DEVICE FROM THE PT. CUSTOMER STATED THAT NO ADD'L PT OR EVENT DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191049 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN (B)(4)| THREE ALARIS PUMP MODULES: SN: (B)(4)| SN: (B)(4)| MODEL/LOT: UNK| 90ML BAG OF FENTANYL: MFR/MODEL/LOT: UNK| THREE ALARIS PUMP MODULE ADMINSTRATION SETS:| SN: (B)(4)| ALARIS PUMP MODULE: SN (B)(4)