BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ LVP 20D LOW SORB SS 1.2M

    MDR report key: 14962214 · Received July 8, 2022

    Report

    Report Number
    9616066-2022-00857
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 8, 2022
    Report Date
    July 19, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203021143
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 23-JUN-2022. H6: INVESTIGATION SUMMARY: A COMPLAINT OF DAMAGE BELOW THE CAP WAS RECEIVED FROM THE CUSTOMER. A SAMPLE WAS RETURNED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, DAMAGE COULD NOT BE SEEN BELOW OR ON THE CAP. HOWEVER, THE LOWER HALF OF THE SET WAS SEPARATED AT THE FILTER. THE SEPARATION WAS CLEAN WITH NO DAMAGE OBSERVED TO THE FILTER. NO SOLVENT WAS OBSERVED AT THE FILTER CONNECTION SITE. THE LOWER HALF OF THE SET WAS NOT RETURNED WITH THE SAMPLE. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10010453 LOT NUMBER 21085579 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 10AUG2021. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE MANUFACTURING SITE WAS NOTIFIED OF THIS DEFECT. THE ROOT CAUSE WAS DETERMINED TO BE A LACK OF SOLVENT BEING ADDED TO THE CONNECTION SITE OF THE FILTER AND THE LOWER HALF OF THE SET. A NEW FIXTURE WAS ADDED TO PREVENT THIS SEPARATION. THIS SET WAS MANUFACTURING PRIOR TO THIS ADDITION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ LVP 20D LOW SORB SS 1.2M EXPERIENCED A DAMAGE PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEDSIDE RN CALLED THE SAQ RN AFTER FINDING THE PATIENT'S LIPID TUBING BROKEN AND LYING ON THE FLOOR..

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ LVP 20D LOW SORB SS 1.2M EXPERIENCED A DAMAGE PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEDSIDE RN CALLED THE SAQ RN AFTER FINDING THE PATIENT'S LIPID TUBING BROKEN AND LYING ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085522 BD ALARIS¿ LVP 20D LOW SORB SS 1.2M INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10010453 21085579 37613203021143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown