BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3133907 · Received May 1, 2013

    Report

    Report Number
    2016493-2013-00213
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 22, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED INCIDENT OF A PUMP MODULE ERROR OCCURRING DURING AN INFUSION WAS CONFIRMED VIA LOG ANALYSIS BUT WAS FOUND TO NOT BE A REPEATABLE EVENT ON THE RETURNED PUMP MODULE. THE DEVICE EVENT LOG INDICATED THE ERROR EVENT WAS A COMMUNICATION ERROR. THE ASSOCIATED PCU EVENT LOG WAS NOT REC'D PREVENTING THE ABILITY TO CONFIRM THAT A CHANNEL DISCONNECT ALARM EVENT HAD OCCURRED PRIOR TO THE COMMUNICATION ERROR; BY DESIGN AN EXPECTED CHANNEL DISCONNECT ALARM EVENT WOULD HAVE BEEN DISPLAYED FIRST BEFORE THE PUMP MODULE DISPLAYED A COMMUNICATION ERROR. IT IS POSSIBLE THE USER HAD SELECTED THE CONFIRM KEY ON THE PCU, WHICH WOULD RETURN THE PCU DISPLAY BACK TO THE MAIN MENU DISPLAY, PRIOR TO THE CAPTURED PICTURE VIEW REC'D FROM THE CUSTOMER. INSPECTION OF THE LEFT IUI CONNECTOR ON THE RETURNED PUMP MODULE FOUND THE PRESENCE OF FLUID RESIDUE AROUND THE BODY OF THE CONNECTOR. A MAGNIFIED VIEW OF THE PINS OBSERVED SOME CONTAMINATION PRESENT ON A FEW PINS WITH SOME OF THE CONTAMINATE HAVING A BLUISH/GREEN COLOR THAT IS TYPICALLY CONFIRMATION OF PIN CORROSION GROWTH OCCURRING. THE OBSERVED AMOUNT WAS SO SMALL IT IS POSSIBLE IT WAS CROSS CONTAMINATION FROM THE PUMP MODULE IT WAS MATED TOO DURING THE INCIDENT. THE ASSOCIATED PUMP MODULE WAS NOT RETURNED FOR INVESTIGATION. CONTAMINATION OF THE PINS BY FLUIDS IS THE PRIMARY CONTRIBUTOR TO THE LOSS OF ELECTRICAL CONTACT BETWEEN THE CONNECTORS. THE ROOT CAUSE FOR THE EVENT THAT OCCURRED WITH THE RETURNED PUMP MODULE COULD NOT BE DEFINITIVELY ASCERTAINED. THE OBSERVED CONTAMINATION ON THE PINS OF THE LEFT IUI CONNECTOR MAY HAVE BEEN A CONTRIBUTING FACTOR AND THE INHERENT WIPING ACTION OF THE PINS DURING MATING OF CONNECTORS COULD HAVE DISPLACED THE OFFENDING CONTAMINATE OUTSIDE OF THE PIN CONTACT AREA.

    Description of Event or Problem · 1

    BIOMED REPORTED WHILE ON A PT, THE PUMP MODULE ALARMED FOR "ERROR" WHICH SCROLLED ON THE CHANNEL MESSAGE DISPLAY. LIGHTS WERE RED, BUT IT WAS REPORTED THAT THE PUMP WAS STILL INFUSING. NO INFO WAS DISPLAYED ON THE PCU. PCU WAS NOT SEQUESTERED. BIOMED SENT A PICTURE FROM THE EVENT. THE PICTURE SHOWS THAT THE AFFECTED PUMP WAS CHANNEL D AND HAS AN ERROR. THE CHANNEL INDICATOR ON THE PUMP IS NOT LIT UP AND THE PCU DOES NOT LIST CHANNEL D. THE BIOMED REPORTED THAT THERE ARE TWO ERRORS IN THE ERROR LOG OF 240.1450 (BOTTLE SIDE PRESSURE SENSOR VOLTAGE TOO HIGH). THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION REPORTED. NO ADD'L PT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190988 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FOUR ALARIS PUMP MODULE ADMINISTRATION SETS:| ALARIS PC UNIT: SN (B)(4)| THREE ALARIS PUMP MODULES: SNS UNK| MODEL/LOT UNK