BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE PUMP

    MDR report key: 11325252 · Received February 12, 2021

    Report

    Report Number
    2016493-2021-25337
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    February 3, 2021
    Report Date
    February 3, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO: B5 PEDIATRIC.

    Additional Manufacturer Narrative · 0

    CORRECTION: DISREGARD FILE, SUSPECT DEVICE WAS DETERMINED TO BE A CONCOMITANT THROUGH FAILURE INVESTIGATION. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2021-25341, WHICH CAPTURED THE SUSPECT DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT THE START OF THE SHIFT (2300) THE RN DOUBLE CHECKED ALL MEDICATIONS/INFUSIONS WITH OFF-GOING NURSE, INCLUDING THE ALPROSTADIL (PGE), WHICH HAD BEEN HUNG PRIOR TO MY ARRIVAL @ 2300 BY OFFGOING RN. ALL INFUSIONS WERE FOUND TO BE RUNNING AT THE APPROPRIATE CONCENTRATION AND DOSE PER SETUP. AROUND 0600 THE SYRINGE PUMP WAS READING "SYRINGE EMPTY" ON THE PGE DESPITE THE BRAIN PUMP REFLECTING THAT THERE SHOULD BE ALMOST 45 MINUTES LEFT IN THE SYRINGE BY VOLUME. THE NURSE HAPPENED TO HAVE HAD THIS PATIENT THE PREVIOUS NIGHT SHIFT AND SHE QUESTIONED WHY THE PGE SYRINGE COULD BE EMPTY ALREADY IF A NEW ONE WAS HUNG OVERNIGHT, AS IN HER EXPERIENCE THIS SYRINGE SHOULD LAST FOR 12 HOURS (31 HOURS IS THE RUNTIME BASED ON 2.5MLS SYRINGE THAT HAD TUBING PRIMED WITH SEPARATE SYRINGE). IT WAS DETERMINED THAT THE PATIENT GOT APPROX. 31 HOURS¿ WORTH OF MEDICATION AT PRESCRIBED DOSE OVER ABOUT 9 HOURS. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT THE START OF THE SHIFT (2300) THE RN DOUBLE CHECKED ALL MEDICATIONS/INFUSIONS WITH OFF-GOING NURSE, INCLUDING THE ALPROSTADIL (PGE), WHICH HAD BEEN HUNG PRIOR TO MY ARRIVAL @ 2300 BY OFFGOING RN. ALL INFUSIONS WERE FOUND TO BE RUNNING AT THE APPROPRIATE CONCENTRATION AND DOSE PER SETUP. AROUND 0600 THE SYRINGE PUMP WAS READING "SYRINGE EMPTY" ON THE PGE DESPITE THE BRAIN PUMP REFLECTING THAT THERE SHOULD BE ALMOST 45 MINUTES LEFT IN THE SYRINGE BY VOLUME. THE NURSE HAPPENED TO HAVE HAD THIS PATIENT THE PREVIOUS NIGHT SHIFT AND SHE QUESTIONED WHY THE PGE SYRINGE COULD BE EMPTY ALREADY IF A NEW ONE WAS HUNG OVERNIGHT, AS IN HER EXPERIENCE THIS SYRINGE SHOULD LAST FOR >12 HOURS (31 HOURS IS THE RUNTIME BASED ON 2.5MLS SYRINGE THAT HAD TUBING PRIMED WITH SEPARATE SYRINGE). IT WAS DETERMINED THAT THE PATIENT GOT APPROX. 31 HOURS¿ WORTH OF MEDICATION AT PRESCRIBED DOSE OVER ABOUT 9 HOURS. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED. BECAUSE NO DEVICE OR DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSION OF ALPROSTADIL (PGE) WAS PROGRAMMED ON A SYRINGE PUMP TO RUN FOR 30 HOURS, BUT COMPLETED WITHIN 9 HOURS. ALTHOUGH REQUESTED, NO FURTHER INFORMATION REGARDING PATIENT INVOLVEMENT AND OUTCOME WAS PROVIDED. PATIENT HARM IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217125 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1 8015,CAD SYR TUBE, TD (B)(6) 2021.