BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTES

    MDR report key: 14119071 · Received April 15, 2022

    Report

    Report Number
    3012307300-2022-06467
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Report Date
    September 27, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027192
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. SAMPLE RECEIVED: THREE SAMPLES WERE RECEIVED; SAMPLES CONSIST IN TWO CASSETTE PRODUCTS FROM PART NUMBER 21-7302-24 AND ONE FROM PART NUMBER 21-7002-24. SAMPLES WERE RECEIVED IN USED CONDITIONS, DECONTAMINATED AND INSIDE IN A PLASTIC BAG. VISUAL INSPECTION RESULTS: SAMPLES RECEIVED DON?T PRESENT ANY DAMAGED, KINK, CUT OR CONDITION THAT COULD CAUSE FAILURE MODE. FUNCTIONAL TESTING: SAMPLES WERE FILLED WITH 100 ML OF WATER; THE SAMPLES WERE CONNECTED TO A PUMP TO LOOK FOR UNUSUAL FUNCTION. RESULTS: SAMPLES WERE FULLY PRIMING AND CONNECTED WITHOUT DIFFICULT, IN TWO OF THE THREE SAMPLES TESTED THE NO DISPOSABLE ALARM WERE ACTIVATED. COMPLAINT IS CONFIRMED. A CAPA WAS OPENED TO ADRESS THE ISSUE AND IDENTIFY THE ROOT CAUSE. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A DHR (DEVICE HISTORY REVIEW) WAS PERFORMED AND NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAS BEEN HAVING PROBLEMS WITH CADD LEGACY PUMPS AND CASSETTES SINCE THE END OF (EXACT DATES UNKNOWN). PUMP ISSUES ALSO REPORTED ON A SEPARATE REPORT: NO NEW INFO PROVIDED. PATIENT PROVIDED LOT NUMBERS FOR BAD CASSETTES: 15 UNOPENED CASSETTES LOT NUMBER 4173645, EXPIRATION DATE 12/20/2021; 1 CASSETTE LOT NUMBER 4213379, EXPIRATION DATE 02/12/2022 OR 02/13/2022; 1 CASSETTE LOT NUMBER 4220001, EXPIRATION DATE 02/08/2022. INFORMED PATIENT THAT WE WILL HAVE NURSE REACH OUT TO MAKE SURE SHE IS USING CASSETTES AND PUMP PROPERLY. DEFECTIVE CASSETTES WILL BE RETURNED. PATIENT DID NOT NEED ANY REPLACEMENT CASSETTES AT THIS TIME. NO FURTHER INFORMATION GIVEN. 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 (MFR) REPLACE THE CASSETTE? NO; 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. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM CUSTOMER ON 29-MAR-2022 AND ATTACHED BY ICU MEDICAL IN COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167179 CADD MEDICATION CASSETTES SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7300-24 4173645 10610586027192

    Patients

    Seq Age Sex Outcome Treatment
    1 Female