BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 14497029 · Received May 25, 2022

    Report

    Report Number
    1314492-2022-02083
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    March 23, 2022
    Report Date
    June 23, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, 'THE PUMP WAS NOT ABLE TO DELIVER THE MEDS FOR ABOUT 7 HOURS DID NOT OCCUR. EVALUATION INSPECTED THE DEVICE DURING FLOW ACCURACY TEST, AND THE PERCENT ERROR RESULTS WERE 1.24%,1.73%, 0.41% WHICH ARE WITHIN SPECIFICATION. A REVIEW OF THE EVENT HISTORY LOG (EHL) REVEALED THE GIVEN PARAMETERS WAS RAN THE DAY OF THE REPORTED EVENT DATE AT TIME STAMP 22:11 WITH MULTIPLE DOSE/RATE CHANGES UNTIL THE DAY AFTER THE REPORTED EVENT DATE AT TIMESTAMP 03:52. REVIEW OF THE EHL COULD NOT CONFIRM THE REPORTED PROBLEM OR IDENTIFY THE DIRECT CAUSE OF THE EVENTS. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED SYMPTOM WAS NOT DUE TO DEVICE MALFUNCTION OF THE SPECTRUM INFUSION PUMP; HOWEVER, IT CANNOT BE DEFINITIVELY CONFIRMED IF USE ERROR CAUSED OR CONTRIBUTED TO THE EVENT. THERE IS CURRENTLY AN OPEN FIELD ACTION (FA-2021-056) ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP AND DETECTION OF UPSTREAM OCCLUSION FOR SPECTRUM PUMPS. NO FURTHER ACTION REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM PUMP DID NOT DELIVER MEDICATION TO THE PATIENT FOR APPROXIMATELY SEVEN HOURS DURING THE INFUSION OF DILAUDID (HYDROMORPHONE) IN THE INTENSIVE CARE UNIT. THE PATIENT EXPERIENCED AN UNDER INFUSION AND DID NOT RECEIVE APPROPRIATE SEDATION AND ANALGESIA. THE PUMP WAS OBSERVED TO NOT BE PULLING FLUID FROM THE BAG AND THE HYDROMORPHONE BAG REMAINED FULL. NO OCCLUSION ALARM WAS GENERATED. THE PATIENT WAS IN DISTRESS AND BECAME INCREASINGLY RESTLESS DESPITE INTRAVENOUS BOLUS DOSES. A NEW PUMP WAS USED AND THE PATIENT RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877280 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Required Intervention DILAUDID