BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ALTA

    MDR report key: 23835470 · Received December 17, 2025

    Report

    Report Number
    2015691-2025-10297
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    December 4, 2025
    Report Date
    March 4, 2026
    Manufacturer
    EDWARDS LIFESCIENCES IRVINE
    Product Code
    DQE
    UDI-DI
    00690103217971
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: QAQ- ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR, MUD- OXIMETER, TISSUE SATURATION, DXN- SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, DSB- PLETHYSMOGRAPH, IMPEDANCE, FLL- THERMOMETER, ELECTRONIC, CLINICAL, QMS- ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER, QNL- MEDIUM-TERM ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR, QEM- CEREBRAL OXIMETER, DQK- COMPUTER, DIAGNOSTIC, PROGRAMMABLE. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW HAS NOT YET BEEN COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    ONE HEMOSPHERE ALTA MONITOR WAS RETURNED FOR PRODUCT EVALUATION. THE CUSTOMER REPORT OF INACCURATE VALUES WAS CONFIRMED. WHEN EVALUATED, MEASURE BT CURRENT FAILED CONSISTENTLY ON THE FUNCTIONAL TESTER. REMOVED THE REAR PANEL AND FOUND A SCREW SITTING BETWEEN TWO PINS TOWARDS THE TOP OF THE SWAN - GANZ RECEPTACLE. THE MAGNET IN THE CONNECTOR WAS HOLDING IT THERE. AFTER REMOVING THE SCREW, THE SWAN INTERFACE TESTS PASSED. NO DAMAGE WAS FOUND. THE BD APM INVESTIGATOR IDENTIFIED THE SCREW AS ONE USED ON THE ALTA TO SECURE THE SWAN RECEPTACLE AND ALL THE OTHER CONNECTORS ON THAT SIDE OF THE DEVICE. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE REPORT OF INACCURATE VALUES WAS CONFIRMED DUE TO AN ELECTRICAL SHORT. THE ELECTRICAL SHORT WAS CAUSED BY A SCREW SITTING BETWEEN TWO PINS TOWARDS THE TOP OF THE SWAN - GANZ RECEPTACLE. THERE WAS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE ALTA CARDIAC MONITOR THE BLOOD TEMPERATURE WAS INCORRECT. THERE WAS NO ALERT OR ERROR MESSAGE FROM THE MONITOR. THE MONITOR WAS DISPLAYING TEMPERATURES OF 89 TO 91 DEGREES. AT THAT POINT IT WAS NOT CALCULATING CO VALUES EITHER. THE REP FIRST REPLACED THE CCO CABLE IN AN ATTEMPT TO TROUBLESHOOT, HOWEVER THE MONITOR AGAIN READ LOW TEMPERATURE WITH NO ALERT BUT WAS CALCULATING CO NUMBERS. TEMPERATURES WERE CONFIRMED BY FOLEY CATHETER. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236 HEMOSPHERE ALTA CATHETER, OXIMETER, FIBER-OPTIC DQE EDWARDS LIFESCIENCES IRVINE ALTACR1 19Y0002059 00690103217971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown