BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 12083402 · Received June 29, 2021

    Report

    Report Number
    3012307300-2021-06617
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    May 31, 2021
    Report Date
    March 3, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: CUSTOMER REPORTED THAT DEVICE SHOWED NO DISPOSABLE ALARM. TAMPER SEALS WERE INTACT, DEVICE WAS CRACKED IN TOP COVER ASSEMBLY. UNABLE TO DUPLICATE REPORT ERROR. PERFORMED VISUAL INSPECTION OF PUMP, PERFORMED NDA TESTING OF PUMP. UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM. REPLACED DSO SENSOR AS A PREVENTIVE MEASURE.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: CUSTOMER REPORTED THAT THERE WAS NO DISPOSABLE PUMP. TAMPER SEALS WERE INTACT, DEVICE WAS CRACKED IN TOP COVER ASSEMBLY.UNABLE TO DUPLICATE REPORT ERROR. PERFORMED VISUAL INSPECTION OF PUMP, PERFORMED NDA TESTING OF PUMP. UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM. REPLACED DSO SENSOR AS A PREVENTIVE MEASURE.

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT DEVICE SHOWED NO DISPOSABLE ALARM. TAMPER SEALS WERE INTACT, DEVICE WAS CRACKED IN TOP COVER ASSEMBLY. UNABLE TO DUPLICATE REPORT ERROR. PERFORMED VISUAL INSPECTION OF PUMP, PERFORMED NDA TESTING OF PUMP. UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM. REPLACED DSO SENSOR AS A PREVENTIVE MEASURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE WAS SHOWING NO DISPOSABLE ALARM. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE SHOWED NO DISPOSABLE PUMP. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE WAS SHOWING NO DISPOSABLE ALARM. NO PATIENT INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD-LEGACY PLUS PUMP EXHIBITED A "NO DISPOSABLE" ALARM DURING USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980229 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown