BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 10909597 · Received November 26, 2020

    Report

    Report Number
    9616066-2020-20461
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    November 1, 2020
    Report Date
    January 18, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403233904
    PMA / PMN Number
    K811885
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF ADAPTER / CONNECTOR DEFECTIVE / DAMAGED COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10014914 LOT NUMBER 20076740 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10014914 LOT NUMBER 20076646 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF CRACKED FEMALE LUER WITH LOT #20076740 REGARDING ITEM #10014914. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF CRACKED FEMALE LUER WITH LOT #20076646 REGARDING ITEM #10014914 .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 AS SYR PSD MICROBORE FROM LOT 20076740 AND 1 DEVICE FROM LOT 20076646 HAD ISSUES WITH CRACKS. AS A RESULT, THE PATIENTS DID NOT RECEIVE THEIR FULL DOSE OF MEDICATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD TWO MORE INSTANCES OVER THE WEEKEND OF TUBING SET 10014914 CRACKING IN THE SAME LOCATION. THIS CONTINUES TO IMPACT OUR PATIENT CARE AND IS PUTTING OUR PATIENTS AT RISK BOTH FOR INFECTION AND AIR EMBOLISM, NOT TO MENTION, WHEN THESE SETS CRACK AND LEAK, THEY ARE NOT RECEIVING THEIR MEDICATIONS. WE HAD TWO LOT NUMBERS STOCKED IN OUR UNIT: (10)20076740 AND (10)20076646." "SYRINGES WERE ATTACHED DIRECTLY TO THE FEMALE LUER. TWO WERE INTERMITTENT MEDICATION LINES, WHICH ARE CHANGED OUT EVERY 24 HOURS. CEFEPIME, LASIX (BOTH IN BD SYRINGES), AND PRE-FILLED 3 ML SALINE FLUSHES (MONOJECT) ARE THE ONLY MEDICATIONS/FLUIDS THAT WENT THROUGH THOSE LINES BEFORE THE LEAKING WAS DETECTED. THE REPORT FROM LAST WEEK INVOLVED A CONTINUOUS MILRINONE INFUSION. WE DO NOT USE ANY ALCOHOL OR CHEMICALS ON THE FEMALE LUERS PRIOR TO CONNECTING THE SYRINGES, AND WE DO NOT USE HEMOSTATS ON THESE PIECES. THE SYRINGES ARE NOT BEING OVER TIGHTENED. THIS EXACT ISSUE HAS BEEN OCCURRING WITH THIS AND OTHER BD PRODUCTS THAT UTILIZE THIS FEMALE LUER CONNECTOR SINCE I ASSUMED THIS ROLE IN 2011. SEVERAL RCAS CONDUCTED IN 2016 INDICATED THE ISSUE WAS ¿SUPPLIER-RELATED¿ BUT PROVIDED NO OTHER DETAILS (PR 91041; PR 120977). ALL OTHER RCAS CONFIRMED CRACKS AND LEAKING, BUT FAILED TO IDENTIFY A ROOT CAUSE, OTHER THAN SUGGESTING USER ERROR."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 20076740. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2020-07-16. MEDICAL DEVICE LOT #: 20076646. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2020-07-14. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 AS SYR PSD MICROBORE FROM LOT 20076740 AND 1 DEVICE FROM LOT 20076646 HAD ISSUES WITH CRACKS. AS A RESULT, THE PATIENTS DID NOT RECEIVE THEIR FULL DOSE OF MEDICATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD TWO MORE INSTANCES OVER THE WEEKEND OF TUBING SET 10014914 CRACKING IN THE SAME LOCATION. THIS CONTINUES TO IMPACT OUR PATIENT CARE AND IS PUTTING OUR PATIENTS AT RISK BOTH FOR INFECTION AND AIR EMBOLISM, NOT TO MENTION, WHEN THESE SETS CRACK AND LEAK, THEY ARE NOT RECEIVING THEIR MEDICATIONS. WE HAD TWO LOT NUMBERS STOCKED IN OUR UNIT: (10)20076740 AND (10)20076646." "SYRINGES WERE ATTACHED DIRECTLY TO THE FEMALE LUER. TWO WERE INTERMITTENT MEDICATION LINES, WHICH ARE CHANGED OUT EVERY 24 HOURS. CEFEPIME, LASIX (BOTH IN BD SYRINGES), AND PRE-FILLED 3 ML SALINE FLUSHES (MONOJECT) ARE THE ONLY MEDICATIONS/FLUIDS THAT WENT THROUGH THOSE LINES BEFORE THE LEAKING WAS DETECTED. THE REPORT FROM LAST WEEK INVOLVED A CONTINUOUS MILRINONE INFUSION. WE DO NOT USE ANY ALCOHOL OR CHEMICALS ON THE FEMALE LUERS PRIOR TO CONNECTING THE SYRINGES, AND WE DO NOT USE HEMOSTATS ON THESE PIECES. THE SYRINGES ARE NOT BEING OVER TIGHTENED. THIS EXACT ISSUE HAS BEEN OCCURRING WITH THIS AND OTHER BD PRODUCTS THAT UTILIZE THIS FEMALE LUER CONNECTOR SINCE I ASSUMED THIS ROLE IN 2011. SEVERAL RCAS CONDUCTED IN 2016 INDICATED THE ISSUE WAS ¿SUPPLIER-RELATED¿ BUT PROVIDED NO OTHER DETAILS (PR 91041; PR 120977). ALL OTHER RCAS CONFIRMED CRACKS AND LEAKING, BUT FAILED TO IDENTIFY A ROOT CAUSE, OTHER THAN SUGGESTING USER ERROR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375109 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10014914 SEE SECTION H.10. 50885403233904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other