BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION PUMP MOUNT (POST MOUNT)

    MDR report key: 2162333 · Received May 10, 2011

    Report

    Report Number
    1640663-2011-00001
    Event Type
    Death
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 10, 2011
    Manufacturer
    MODULAR SERVICES COMPANY
    Product Code
    FOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTS THAT THE INFUSION PUMP MOUNT WAS PUSHED OUT OF ITS MOUNTINGS BY BEING CAUGHT ON THE BED RAIL WHILE TWO NURSES WERE RAISING THE HEAD OF THE BED. THE BED RAIL PUSHED THE IV POLE MOUNTING POST UP AND OUT OF ITS MOUNTINGS, CAUSING IT TO TIP OVER ONTO THE PT, HITTING HIS HEAD. OUR RECORDS INDICATE THAT THE DEVICE WAS SHIPPED TO THE USER FACILITY APPROXIMATELY SIX YEARS AGO. INFUSION PUMP MOUNT COMPONENTS ON HAND HAVE BEEN REVIEWED AND ARE WITHIN ACCEPTABLE LIMITS. THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. PICTURES AND/OR DESCRIPTIONS OF THE DEVICE LOCATION, INSTALLATION AND THE NUMBER AND TYPE OF INFUSION PUMPS MOUNTED ON THE DEVICE AT THE TIME OF THE EVENT HAVE NOT BEEN PROVIDED. VERBAL DISCUSSIONS WITH USER FACILITY PERSONNEL INDICATE THAT ONE OF THE TWO MOUNTING POSTS MAY HAVE BEEN MISSING FROM THE INFUSION PUMP MOUNT AT THE TIME OF THE EVENT. THE DEVICE CODE ENTERED BY THE USER FACILITY INDICATES AN INSTALLATION RELATED AND PROTECTIVE MEASURES ISSUE. THE DEVICE WAS INSTALLED BY THE USER FACILITY AND IS MAINTAINED BY THEM. THE DESCRIPTION OF THE EVENT IMPLIES ATTENDANTS DID NOT CLEAR ALL SURROUNDING DEVICES AND EQUIPMENT BEFORE OPERATING THE POWERED BED. OUR INVESTIGATION WILL BE CONTINUED IF THE DEVICE IS RETURNED AND/OR ADDITIONAL INFO IS PROVIDED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED: AT 2020 ON (B)(6) 2011, PT WAS ON BEDSIDE COMMODE. AT 2040, TWO NURSES GOT PT BACK INTO BED AND WENT TO RAISE THE HEAD OF THE BED. THE SIDE RAIL CAUGHT ON THE IV POLE PUSHING THE IV POLE UP AND OUT OF ITS MOUNTING, (THE POLES ATTACHED TO THE WALL TIPPING IT OVER ONTO THE PT AND HIT HIS HEAD. THE IV POLE WAS CAUGHT BEFORE ALL OF ITS WEIGHT LANDED ON THE PT. PT HAD A SCRATCH ON HIS FOREHEAD AND RIGHT EYEBROW. THE SCRATCHES BLED FOR A MOMENT AND THEN STOPPED. PT WAS ORIENTED AND VITAL SIGNS STABLE, THE PHYSICIAN WAS NOTIFIED AT 2100, NO NEW ORDERS RECEIVED. ICE WAS APPLIED TO THE FOREHEAD AND PT REMAINED ORIENTED AND STABLE. AT APPROXIMATELY 01:30 ON (B)(6) 2011, THERE WAS EVIDENCE OF NEUROLOGICAL CHANGES, INITIALLY, INCREASED URINE OUTPUT. THE PT WAS TAKEN TO CT WHERE THE CT SHOWED A CEREBRAL HEMORRHAGE. AT THAT TIME, IT WAS DETERMINED THAT SURGICAL INTERVENTION WAS NOT AN OPTION, AND THE FAMILY WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION PUMP MOUNT (POST MOUNT) INFUSION PUMP MOUNT, SINGLE FOX MODULAR SERVICES COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death