BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1260725 · Received December 10, 2008

    Report

    Report Number
    2016493-2008-00212
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 27, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    L012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING; REQUESTED DEVICE EVENT LOG ALONG WITH CURRENT DATASET, LOG WAS REC'D BUT NOT DATASET. ADD'L REQUESTS HAVE BEEN MADE FOR THE DATASET; TO DATE, IT HAS NOT BEEN PROVIDED. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    INITIAL REQUEST FROM CUSTOMER ASSISTANCE WITH LOG DOWNLOADED AND INTERPRETATION FOR AN UNK PT INCIDENT. SUBSEQUENTLY, WE WERE INFORMED THAT THE PT WAS ON A NOREPINEPHRINE DRIP AT 1-2 ML/HR TITRATED TO BLOOD PRESSURE; NURSE HUNG NEW BAG WITH 16 MG NOREPI IN 250 ML AT ABOUT 10:30 PM, BAG WAS FOUND EMPTY AT 12:15 AM. PT HAD TRANSIENT HYPERTENSION AND TACHYCARDIA AND REQUIRED SEDATION UNTIL HE STABILIZED. ULTIMATELY BLOOD PRESSURE RETURNED TO NORMAL THEN DROPPED AGAIN REQUIRING ON-GOING SUPPORT, AS HE DID BEFORE THE OVERINFUSION OCCURRED. REPORTED NO LONG-TERM NEGATIVE IMPACT ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN, INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention ALARIS SYS PC UNIT| ALARIS SYS PUMP MODULES