BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 21260775 · Received January 28, 2025

    Report

    Report Number
    2015691-2025-00539
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 13, 2025
    Report Date
    January 28, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQK
    UDI-DI
    00690103202762
    PMA / PMN Number
    K201446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED FOR RETURN BUT HAS NOT YET ARRIVED FOR EVALUATION. WHEN IT HAS ARRIVED AND HAS BEEN EVALUATED THE FINDINGS WILL BE SENT IN A SUPPLEMENTAL SUBMISSION. THE DEVICE HISTORY RECORD REVIEW IS PENDING. WHEN IT HAS BEEN COMPLETED THE RESULTS WILL BE SENT IN A SUPPLEMENTAL SUBMISSION. ADDITIONAL PRODUCT CODES, DQE, QAQ, MUD, DSB, QMS, FLL, DXN.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THAT THERE WERE INACCURATE BLOOD PRESSURE VALUES WITH THE CLEARSIGHT MODULE. THE DISPLAYED NUMBERS WERE 20 TO 40 POINTS DIFFERENT FROM THE BLOOD PRESSURE CUFF READING. THE CLEARSIGHT READING WOULD STOP AND A FAULT MESSAGE OF "PUMP MALFUNCTION" WAS DISPLAYED. WHEN THIS OCCURRED, THEY WOULD HAVE TO RESTART THE MONITOR. THE PUMP UNIT WAS RULED OUT AS A SUSPECT DEVICE AS WHEN IT WAS REPLACED THE ISSUE STILL OCCURRED. THE CLEARSIGHT MODULE WAS REPLACED FOR A DIFFERENT ONE AND THEN EVERYTHING WORKED WITHOUT FURTHER INCIDENT. THERE IS NO PHYSICAL DAMAGE SEEN ON THE MODULE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THE PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. THERE IS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953239 HEMOSPHERE CLEARSIGHT MODULE DQK EDWARDS LIFESCIENCES HEMCSM10 00690103202762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown