BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE THIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1231383 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88329
    Event Type
    Injury
    Date Received
    November 17, 2008
    Date of Event
    May 22, 2007
    Report Date
    May 29, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE.LTD
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON-SITE EVALUATION WAS PERFORMED BY BAXTER PAL LAB TECHNICIAN ON 06/01/07. THE EVENT WAS DOWNLOADED AND REVIEWED ON THE CUSTOMER SITE. THE EVENT HISTORY CONTAINED THE LAST 1000 EVENTS RANGING FOR FIVE DAYS. THERE WERE NO FAILURES FOUND IN THE EVENT HISTORY (OCCURRENCE DATE). THE PUMP¿S DATE WAS ONE DAY OFF (LOCAL DATE: 2007, PUMP¿S DATE: ONE DAY PRIOR). THE REPORTED OCCURRENCE DATE WAS REVIEWED. THE KEY PRESSES REVEALED THAT THE DOSE MODES (PATIENT WEIGHT) WAS SELECTED ON CHANNEL B AND THE UNITS/KG/HR WAS SELECTED. THE DRUG AMOUNT WAS KEYED IN AT 2500MG, THE DILUENT AMOUNT WAS 250ML, THE DOSE AT 15MG/KG/HR RESULTING IN A RATE OF 81.6ML/HR WITH A VOLUME OF 250ML. CHANNEL B WAS RUN AT 81.6ML/HR FROM 01:00:36 UNTIL (KEEP VEIN OPEN) KVO OCCURRED AT 04:04:24. THE PUMP WAS LEFT IN KVO MODE FOR APPROXIMATELY 1 HOUR UNTIL THE STOP B PRESS OCCURRED AT 07:59:51. THE VOLUME WAS CHANGED TO 10ML AND AN INCOMPLETE PRIM. PROG. SET OCCURRED BECAUSE THE CONFIRM SETTINGS (SOFT KEY #4) WAS NOT PRESSED. THE CONFIRM SETTINGS WAS SELECTED AND CHANNEL B WAS RUN AT 81.6ML/HR FROM 08:00:07 THROUGH 08:03:23 (APPROXIMATELY 3 MINUTES) UNTIL THE STOP B PRESS. CHANNEL B WAS SELECTED AND THE DRUG AMOUNT WAS CHANGED TO 25000MG AND THE VOLUME WAS CHANGED TO 200ML. THE PUMP WAS EVALUATED. CUSTOMER KEY PRESSES WERE PERFORMED PER THE EVENT HISTORY LINES 425 ¿ 473 RESULTING IN AN INFUSION RATE OF 81.6ML/HR. AND IT WAS DETERMINED THAT THE 8.2 ML/HR WAS THE DESIRED RATE FOR A CONCENTRATION OF HEPARIN 25000 UNITS IN 250 ML. THE PUMP ACCURACY TESTS SHOWED THAT THE PUMP UNDER DELIVERED ON CHANNELS A AND C BUT DID NOT OVER DELIVER. THE ASSIGNABLE CAUSE FOR THE OVER INFUSION WAS MISPROGRAMMING ERROR BY THE USER.

    Additional Manufacturer Narrative · 1

    BAXTER ENGINEERS REVIEWED THE COMPLAINT DATA FOR THE PERIOD OF 2005 THROUGH 2007 AND THERE IS NO TREND FOR THE REPORTED FAILURE. THE ROOT CAUSE OF THE DATE ERROR IS UNKNOWN. THE FACILITY WAS INFORMED OF THE EVALUATION RESULTS SINCE THEY WERE PRESENT DURING THE ON-SITE VISIT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE RISK MANAGER AT THE FACILITY AND WAS ENTERED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PATIENT, AGE UNKNOWN, WHO HAD RECEIVED AN OVER INFUSION OF HEPARIN VIA AN INFUSION PUMP. THE PATIENT HAD A HISTORY OF DEEP VEIN THROMBOSIS (DVT). HEPARIN 25,000 UNITS/250 SALINE WAS HUNG IN 2007 AT 0100. REPORTEDLY THE NURSE HAD THE PUMP PROGRAMMED CORRECTLY BUT DID NOT DO THE ¿PROTOCOL FOR 2 PERSON CHECK.¿ THE INCIDENT WAS DISCOVERED THE SAME MORNING AT 0830 WHEN A SECOND NURSE (AFTER CHANGE OF SHIFT) ASSESSED THE PATIENT AND FOUND THE PUMP RATE TO BE 81 RATHER THAN 8.1. THE PATIENT WAS NOTED TO HAVE A SMALL AMOUNT OF OOZING BLOOD AROUND HIS CVP LINE. PTT WAS DRAWN AND WAS GREATER THAN 150. THE HEPARIN DRIP WAS HELD AND RESTARTED AGAIN AT 21:30 OF THE SAME DAY. THE PATIENT REMAINS HOSPITALIZED AT THIS TIME. IN ADDITION, THE RISK MANAGER REPORTS THAT IT APPEARS THAT THE PUMP MAY HAVE BEEN DROPPED, SINCE THE BACK OF IT WAS ¿LOOSE¿ AND WHEN THE BIOMEDICAL TECHNICIAN TURNED THE PUMP ON, THERE WERE LINES IN THE DISPLAY, AND COULD NOT READ ANYTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE THIPLE CHANNEL VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE.LTD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention