BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PCA ADMINISTRATION SET

    MDR report key: 18480472 · Received January 9, 2024

    Report

    Report Number
    9616066-2023-02504
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 5, 2023
    Report Date
    January 17, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403273955
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINTS OF 4 ISSUES: 1. A DISCONNECTION FROM A PATIENT, FROM THE PCA TUBING; 2. & 3. TUBING HAD HOLES AND CRACKS IN IT; 4. A BREAK IN THE TUBING WHERE IT CONNECTS TO THE SYRINGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED WITHOUT A FAILURE INVESTIGATION. DEVICE HISTORY RECORD REVIEW FOR MODEL 30883 LOT NUMBER 22095083 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) IN 1 LOT NUMBER WAS BUILT ON 06SEP2022. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO NEW ADDITIONAL INFORMATION: MATERIAL#: 30883, BATCH NUMBER#: 22095083. IT WAS REPORTED BY CUSTOMER THAT THEY HAD FOUR SEPARATE ISSUES: FIRST A DISCONNECTION FROM A PATIENT, FROM THE PCA TUBING, SECOND AND THIRD, TUBING HAD HOLES AND CRACKS IN IT. FOURTH A BREAK IN THE TUBING WHERE IT CONNECTS TO THE SYRINGE. VERBATIM# "WE HAVE HAD FOUR SEPARATE ISSUES: FIRST A DISCONNECTION FROM A PATIENT, FROM THE PCA TUBING, SECOND AND THIRD, TUBING HAD HOLES AND CRACKS IN IT. FOURTH A BREAK IN THE TUBING WHERE IT CONNECTS TO THE SYRINGE". CUSTOMER REPLY: CONFIRM WHETHER THE FOUR INCIDENTS HAPPENED IN THE SAME DATE. IF NOT, PLEASE PROVIDE THE DATES SEPARATELY. HAPPENED ON DIFFERENT DATES, WE WORK 12 HOUR SHIFTS SO TIMES AS ESTIMATES ONLY: 12/5/23 @ 2300- PCA MICRO BORE TUBING FOUND DISCONNECTED FROM SYRINGE, MEDICATION LEAKED ONTO FLOOR. 12/11/23 @ 0900- PCA TUBING MICRO BORE TUBING LEAKING MEDICATION ON FLOOR, DEFECTS FOUND IN PCA SMALL BORE TUBING. 12/12/23 @ 2130 -PCA TUBING MICRO BORE TUBING LEAKING MEDIATION ON FLOOR, DEFECTS FOUND IN PCA SMALL BORE TUBING. 12/14/23 @ 0800-LUER LOCK ON PCA SYRINGE BROKE OFF FROM PCA TUBING. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT. NO PATIENT HARM WAS FOUND, OTHER THAN HAVING TO WASTE A MEDICATION. PLEASE CONFIRM ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION. IF YES, PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? I HAVE SAMPLES STORED AWAY THAT CAN BE SENT BACK, I WILL GET THEM TODAY AND SEND THEM TO (B)(4) TO GET BACK TO YOU. DID ALL THE FOUR EVENTS OCCURRED IN THE SAME PRODUCT. IF NOT, PLEASE PROVIDE THE DETAILS. THREE EVENTS OCCURRED WITH THE PCA TUBING, ANOTHER WAS WITH A SYRINGE THAT CONNECTS TO THIS SAME TUBING AS DETAILED IN ORIGINAL MESSAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS PCA ADMINISTRATION SET DISCONNECTED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: "WE HAVE HAD FOUR SEPARATE ISSUES: FIRST A DISCONNECTION FROM A PATIENT, FROM THE PCA TUBING, SECOND AND THIRD, TUBING HAD HOLES AND CRACKS IN IT. FOURTH A BREAK IN THE TUBING WHERE IT CONNECTS TO THE SYRINGE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590315 BD ALARIS PCA ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 22095083 50885403273955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown