BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP

    MDR report key: 9803966 · Received March 8, 2020

    Report

    Report Number
    3012307300-2020-01932
    Event Type
    Malfunction
    Date Received
    March 8, 2020
    Report Date
    April 16, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B5 WAS UPDATED TO REFLECT NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP EXHIBITED ALARM "SETTINGS LOST" WHEN TURNED ON EVERY TIME. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: ONE CADD SOLIS VIP WAS RETURNED FOR INVESTIGATION IN USED CONDITION. A REVIEW OF THE EVENT HISTORY LOG EVIDENCED THE FOLLOWING: "(B)(6) 2005 12:00:07 AM MEDIUM ALARM DISPLAYED: PUMP SETTINGS AND PATIENT DATA LOST. (B)(6) 2005 12:00:12 AM MEDIUM ALARM ACKNOWLEDGED: PUMP SETTINGS AND PATIENT DATA LOST. (B)(6) 2005 12:00:15 AM INFO ALARM: USB CABLE ATTACHED." THE CUSTOMER REPORTED PRODUCT PROBLEM WAS REPLICATED. THE ERROR "PUMP SETTINGS AND PATIENT DATA LOST" WAS DUPLICATED AT POWER UP. THE PRODUCT PROBLEM WAS ATTRIBUTED TO THE INTERNAL BACKUP BATTERY BEEN DRAINED OUT. THE CUSTOMER MAY HAVE LEFT THE PUMP SITTING IN THE STORAGE FOR A LONG PERIOD OF TIME WITHOUT POWERING UP THE DEVICE. THE PUMP WAS POWERED FOR AN EXTENDED PERIOD OF TIME SO THE INTERNAL BACKUP BATTERY COULD CHARGE. NO PARTS WERE REPLACED. THE PROBLEM SOURCE OF THE REPORTED PRODUCT PROBLEM WAS NOT DEFINITIVELY KNOWN. A ROOT CAUSE WAS THERE NOT ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP EXHIBITED ALARM "SETTINGS LOST" WHEN TURNED ON EVERY TIME. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267330 CADD SOLIS VIP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1