BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SE BLD 15DP 180MF 1VS DEHP FREE

    MDR report key: 10375365 · Received August 6, 2020

    Report

    Report Number
    9616066-2020-02443
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 14, 2020
    Report Date
    July 16, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION. FEEDBACK FROM THE CUSTOMER INDICATES THAT LEAKAGE WAS OBSERVED FROM DAMAGE CLOSE TO THE Y-SITE AT THE START OF INFUSION. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 18035336 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE. WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED OCCURRENCE WITH NO OTHER SIMILAR REPORT AGAINST THE 11499817-09 SET IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SE BLD 15DP 180MF 1VS DEHP FREE EXPERIENCED DEVICE DAMAGE/DEFORMATION, LEAKAGE, AND UNDERINFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INFUSION OF PLATELETS, THE PATIENT (17 YEAR OLD) WARNS THE NURSE THAT THERE IS A LACK OF FLUID IN THE SET AT THE JUNCTION BETWEEN THE DRUGS INJECTION POINT AND THE EXTEMPORANEOUS WAYS (THE LACK WAS NOT FROM THE MEMBRANE BUT FROM THE Y SHAPED PLASTIC). AS A CONSEQUENCE THERE HAS BEEN A REDUCED INFUSION OF PLATELETS DUE TO THE CRACK IN THE SET.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: ONLY THE PATIENT'S AGE WAS GIVEN THEREFORE A DEFAULT DATE OF BIRTH HAS BEEN LISTED A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SE BLD 15DP 180MF 1VS DEHP FREE EXPERIENCED DEVICE DAMAGE/DEFORMATION, LEAKAGE, AND UNDERINFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INFUSION OF PLATELETS, THE PATIENT ((B)(6)) WARNS THE NURSE THAT THERE IS A LACK OF FLUID IN THE SET AT THE JUNCTION BETWEEN THE DRUGS INJECTION POINT AND THE EXTEMPORANEOUS WAYS (THE LACK WAS NOT FROM THE MEMBRANE BUT FROM THE Y SHAPED PLASTIC). AS A CONSEQUENCE THERE HAS BEEN A REDUCED INFUSION OF PLATELETS DUE TO THE CRACK IN THE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841486 SE BLD 15DP 180MF 1VS DEHP FREE INFUSION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 18035336

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other 20200714| 20200714