BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PUMP

    MDR report key: 12632534 · Received October 13, 2021

    Report

    Report Number
    MW5104580
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 20, 2021
    Report Date
    September 21, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL- PUMP MALFUNCTION. PT CONFIRMED PUMP RATE OF 58 ML/24H. STATES SHE USES 2-1.5 MG VIALS/VELETRI PER DAY-CADD LEGACY PUMP SERIAL NUMBER (B)(4) AND SERIAL NUMBER (B)(4) ARE NOT WORKING PROPERLY, SHE THINKS IT IS LEAKING OUT OF THE FILTER ON BOTH PUMPS. HAS PUMP CURRENTLY RUNNING AND STATED SHE WAS ABLE TO PLAY WITH THE PUMP AND STOP THE LEAKING. PT'S CENTRAL LINE WAS REPLACED (B)(6) 2021. PATIENT ALSO STATES SHE WAS MAKING A MIX LAST NIGHT AND WHEN SHE WENT TO REMOVE THE AIR FROM THE CASSETTE, IT EXPLODED (LOT# 4120067) PT IS 8 HOURS AWAY FROM THE NEAREST HOSPITAL THAT DISPENSES VELETRI AND DOES NOT HAVE A DRIVERS LICENSE EITHER. REQUESTING 2 REPLACEMENT PUMPS BE COURIERED TO PT. MAINTENANCE DATES UNKNOWN. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION? YES; DID WE REPLACE THE CASSETTE? YES; DID THE PT HAVE ADD'L CASSETTES THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526332 CADD LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. UNK
    1526333 CADD LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.
    1526334 MEDI RESERVOIR 12X100ML SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4120067

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR