BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 10290169 · Received July 17, 2020

    Report

    Report Number
    1314492-2020-02411
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Report Date
    August 5, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION H3, H6 AND H10: BAXTER RECEIVED AND EVALUATED THE DEVICE. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED CONDITION WAS NOT VERIFIED. THE REPORTED SYMPTOM WAS UNABLE TO BE EVALUATED FOR DUE TO AN UNRELATED ISSUE OCCURRING DURING EVALUATION ON POWER UP. THE PUMP IS NO LONGER IN ITS RECEIVED CONDITION AND THE EVALUATION COULD NOT BE PERFORMED. THE DEVICE IN QUESTION WAS REPAIRED AND TESTED PRIOR TO RELEASE TO ENSURE THE DEVICE MEETS ALL SPECIFICATIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP OVER INFUSED IN THE NEONATAL INTENSIVE CARE UNIT ON A PEDIATRIC PATIENT. THE PEDIATRIC PATIENT WAS BEING INFUSED WITH A 500 ML BAG RUNNING AT 1 CC/H, THE BAG WAS HANGING FOR UNDER 48 HOURS AND WAS OFF FOR 12 HOURS IN THE MIDDLE TO DE-CLOT THE LINE, THE REPORTER STATED THAT APPROXIMATELY 36 CC SHOULD HAVE BEEN INFUSED. IT WAS STATED THAT THE PEDIATRIC PATIENT HAD A SIGNIFICANT WEIGHT GAIN OVERNIGHT OF 160 GRAMS. THERE WAS PATIENT INVOLVEMENT BUT NO KNOWN PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755880 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1