BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 18222573 · Received November 28, 2023

    Report

    Report Number
    2015691-2023-17758
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    November 14, 2023
    Report Date
    July 18, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQK
    UDI-DI
    00690103202762
    PMA / PMN Number
    K201446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLEARSIGHT MODULE WAS RETURNED AND EVALUATED. THE SUSPECT CSM WAS CONNECTED TO A KNOWN GOOD WORKING HEMOSPHERE INSTRUMENT FOR TESTING. THERE WERE NO ERROR MESSAGES THAT DISPLAYED. THERE WERE NORMAL BLOOD PRESSURE READINGS AND A NORMAL WAVEFORM THAT WERE ABLE TO BE ACQUIRED. THE COMPONENTS WERE LEFT TO MONITOR FOR 1.5 HOURS. THE READINGS REMAINED STABLE. THERE WAS NO ISSUE FOUND. A VISUAL INSPECTION FOUND NO DAMAGE TO THE DEVICE. THE REPORTED ISSUE WAS NOT CONFIRMED. THERE WILL BE NO FURTHER ACTION TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED FOR RETURN BUT HAS NOT YET ARRIVED. WHEN IT HAS ARRIVED AND THE PRODUCT EVALUATION HAS BEEN COMPLETED, THE EVALUATION FINDINGS WILL BE SENT IN A SUPPLEMENTAL REPORT. THE DEVICE HISTORY RECORD REVIEW HAS BEEN COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. THE FOLLOWING ARE ADDITIONAL PRODUCT CODES FOR THIS DEVICE: DQE CATHETER, OXIMETER, FIBER-OPTIC. QAQ ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. MUD OXIMETER, TISSUE SATURATION. DSB PLETHYSMOGRAPH, IMPEDANCE. QMS ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER. FLL THERMOMETER, ELECTRONIC, CLINICAL. DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. THE FOLLOWING IS CORRECTED DATA, AS THE ORIGINAL IDENTIFICATION INFORMATION SENT DID NOT MATCH THE DATA SUBMITTED TO THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID) D1 BRAND NAME: HEMOSPHERE . D2A COMMON DEVICE NAME: COMPUTER, DIAGNOSTIC, PROGRAMMABLE. D2B DEVICE PRODUCT CODE: DQK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE CLEARSIGHT MODULE, DURING PATIENT USE. THERE WERE INACCURATE BLOOD PRESSURE READINGS THAT OCCURRED. THE READINGS WERE APPROXIMATELY CS BP 160S/30S, THE NIBP 200S/100S THERE WERE NO ERROR MESSAGES THAT DISPLAYED. THE ISSUE WAS ISOLATED TO THE CSM. THERE WAS NO ARTERIAL LINE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT DEMOGRAPHICS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532369 HEMOSPHERE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES HEMCSM10 00690103202762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown