BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTES

    MDR report key: 14119309 · Received April 15, 2022

    Report

    Report Number
    3012307300-2022-06469
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Report Date
    October 11, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    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: A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. THE SAMPLE RECEIVED DOES NOT PRESENT ANY DAMAGE, KINK, CUT OR CONDITION THAT COULD CAUSE THE FAILURE MODE. THE SAMPLE WAS RECEIVED WITHOUT BLUE CLIP. UPON FUNCTIONAL TESTING THE SAMPLE WAS FULLY PRIMING AND CONNECTED WITHOUT DIFFICULTY, BUT A NO DISPOSABLE ALARM WAS ACTIVATED CONFIRMING THE REPORTED PROBLEM. THE ROOT CAUSE OF THE REPORTED ISSUE IS UNKNOWN. A DHR (DEVICE HISTORY REVIEW) WAS PERFORMED AND NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW. A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED TO ADDRESS THE REPORTED ISSUE.

    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; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. 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
    140635 CADD MEDICATION CASSETTES SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4213379 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Female