BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11988548 · Received June 12, 2021

    Report

    Report Number
    3012307300-2021-05926
    Event Type
    Malfunction
    Date Received
    June 12, 2021
    Report Date
    December 21, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED AFTER DEVICE EVALUATION. H10: DEVICE EVALUATION: THE DEVICES WERE RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. SAMPLES RECEIVED: ON (B)(6) 2021 FIVE (5) CASSETTE UNITS FROM P/N 21-7302-24 L/N 4103166, 4084028 WERE RECEIVED; THE RETURNED SAMPLES WERE RECEIVED IN NEW CONDITION WITHOUT ITS ORIGINAL PACKAGE. ON (B)(6) 2021 SIX (6) ADDITIONAL SAMPLES WERE RECEIVED. THE SAMPLE CONSIST IN SIX (6) CASSETTE PRODUCTS FROM PART NUMBER 21-7302-24, SAMPLES WERE RECEIVED IN USED CONDITIONS, WITHOUT ITS ORIGINAL PACKAGING, DECONTAMINATED AND INSIDE IN A PLASTIC BAG. VISUAL INSPECTION RESULTS: THE SAMPLES DIDN?T PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, ETC. COULD CAUSE THE FAILURE MODE REPORTED. FUNCTIONAL TESTING: SAMPLES WERE FILLED WITH WATER. THE SAMPLES RECEIVED WERE CONNECTED TO THE CADD SOLIS VIP. THE SAMPLE RECEIVED ON 16/AUG/2021 WERE CONNECTED TO THE CADD LEGACY PLUS TO LOOK FOR UNUSUAL FUNCTION. RESULTS: THE ELEVEN (11) SAMPLES WERE FULLY PRIMING AND CONNECTED WITHOUT DIFFICULT, THE PUMP WAS SET RUNNING AND THE ALARM WAS NOT ACTIVATED. THE COMPLAINT WAS NOT CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10010116, AS A RESULT OF WARNING LETTER CMS#(B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. ELEVEN SAMPLES WERE RECEIVED FOR EVALUATION. FIVE WERE RECEIVED IN NEW CONDITION WITHOUT ITS ORIGINAL PACKING AND SIX WERE RECEIVED IN USED CONDITION, WITHOUT ITS ORIGINAL PACKAGING, DECONTAMINATED AND INSIDE IN A PLASTIC BAG. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OBSERVED THE SAMPLES DIDN'T PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, ETC. COULD CAUSE THE FAILURE MODE REPORTED. DURING FUNCTIONAL TESTING, THE SAMPLES WERE FULLY PRIMING AND CONNECTED WITHOUT DIFFICULTLY, THE PUMP WAS SET RUNNING AND THE ALARM WAS NOT ACTIVATED. THE COMPLAINT WAS NOT CONFIRMED AND NO ACTIONS WERE TAKEN. HOWEVER, THERE IS PROCESS CONTROLS IN PLACE FOR THE FAILURE MODE REPORTED. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED. HOWEVER, PER TREND REVIEW FOR NO DISPOSABLE ALARM COMPLAINT CODE AN ESCALATION TO INVESTIGATE THIS FAILURE WAS INITIATED ON APRIL 30, 2021 UNDER NON-CONFORMANCE REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SMITHS MEDICAL CADD LEGACY PCA AND PLUS PUMPS INDICATE NO-DISPOSABLE ATTACHED. AFTER INVESTIGATION DETERMINED PUMP NOT THE ISSUE BUT THE SETS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885152 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 7300 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown