BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    DIGNICAP DELTA SYSTEM

    MDR report key: 12220853 · Received July 23, 2021

    Report

    Report Number
    3012146457-2021-00001
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    May 11, 2021
    Report Date
    July 23, 2021
    Manufacturer
    DIGNITANA INC.
    Product Code
    PMC
    PMA / PMN Number
    K191166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMAL TESTING OF ACTUAL UNIT 21-MAY-2021: ON 5/21/2021, DIGNITANA CLINICAL ACCOUNT MANAGER, (B)(6), WENT TO INCIDENT SITE ((B)(6) HOSPITAL) AND INSPECTED THE ACTUAL DEVICE (SN (B)(4)). NO VISIBLE FLUID WAS OBSERVED UPON ARRIVAL. MACHINE WAS MOVED FROM THE HALLWAY TO THE INSIDE OF TREATMENT ROOM (BAY 7) AND CONDUCTED A HOSE DROP TEST AND FLUID SPILLED FROM THE END OF THE THERAPY HOSE OF WHAT APPEARED TO BE CONDENSATION. FORMAL TESTING OF SIMILAR DEVICE - SAME MODEL 28-MAY-2021: ENGINEERING TESTING CONDUCTED ON A SIMILAR MODEL (DIGNICAP DELTA) BUT NOT THE ACTUAL DEVICE, FOR ONE FULL TREATMENT CYCLE CONCLUDED THAT WATER/CONDENSATION BUILD UP ON THE CONNECTORS (CONNECTING THE THERAPY HOSE TO THE DEVICE) AND INSULATION MATERIAL ON THE THERAPY HOSE COULD BE PRESENT IN QUANTITIES THAT WOULD BE ENOUGH TO WET A SURFACE NEAR THE MACHINE. NO LEAKS WERE FOUND INSIDE THE UNIT, NOR WERE ANY COOLANT LEAKS FOUND. IT IS LIKELY THAT ENVIRONMENTAL FACTORS, TEMPERATURE AND HUMIDITY CONTRIBUTED TO THE BUILD-UP OF CONDENSATION.

    Description of Event or Problem · 1

    DIGNITANA, INC. WAS MADE AWARE ON 5/18/2021 BY STAFF AT (B)(6) CANCER CENTER ((B)(6)) THAT A NURSE SLIPPED AND FRACTURED HER ANKLE. THE INCIDENT OCCURRED ON (B)(6) 2021. A SCALP COOLING TREATMENT TO HELP REDUCE ALOPECIA IN CANCER PATIENTS, DELIVERED BY THE DIGNICAP® DELTA SYSTEM, HAD BEEN ADMINISTERED TO A PATIENT. AFTER THE TREATMENT THE DELTA CONTROL UNIT (CU) WAS MOVED OUTSIDE THE TREATMENT ROOM TO A HALLWAY. IT IS NOT KNOWN IF THE UNIT WAS WIPED DOWN AFTER THE TREATMENT. A NURSE THEN WALKED AROUND THE DEVICE, SLIPPED AND FRACTURED HER FOOT. IN A FOLLOW-UP ON (B)(6) 2021, THE NURSE STATED THAT HER ANKLE IS HEALING AND SHE RETURNED TO WORK ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116141 DIGNICAP DELTA SYSTEM SCALP COOLING SYSTEM PMC DIGNITANA INC. DIGNICAP DELTA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other