BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 15276781 · Received August 23, 2022

    Report

    Report Number
    3012307300-2022-15848
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Report Date
    July 20, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    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

    OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. DEVICE EVALUATION: THE DEVICE HAS NOT BEEN RETURNED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: DEVICE EVALUATION: TAMPER SEAL IS REMOVED. DEVICE IS IN GOOD CONDITION. EVENT HISTORY LOG: MEDIUM ALARM DISPLAYED: PUMP SETTINGS AND PATIENT DATA LOST. ON (B)(6) 2005 12:00:43 AM MEDIUM ALARM SILENCED: PUMP SETTINGS AND PATIENT DATA LOST. ON (B)(6) 2005 12:00:43 AM MEDIUM ALARM ACKNOWLEDGED: PUMP SETTINGS AND PATIENT DATA LOST. PERFORMED FUNCTIONAL CHECK. CUSTOMER PROBLEM WAS DUPLICATED. DURING INVESTIGATION, FOUND MULTIPLE MEDIUM ALARM DISPLAYED: PUMP SETTINGS AND PATIENT DATA LOST IN EVENT HISTORY LOGS. CONNECTED AN AC POWER, CHARGED THE DEVICE FOR THREE DAYS, UNABLE TO CHARGED INTERNAL BATTERIES. REPLACED MPU BOARD. LOW BATTERY VOLTAGE CAUSED THE PROBLEM. PRODUCT IS BEYOND A YEAR FROM MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DHR REVIEW WAS NOT PERFORMED. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE PREVIOUSLY.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: ADDITIONAL INFORMATION RECEIVED ON 19-SEPT-2022 VIA EMAIL AND ATTACHED IN COMPLAINT OBJECT: ALL REFERENCED COMPLAINTS WERE FOUND DURING TESTING. NO PATIENTS WERE INVOLVED OR EFFECTED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES NOT REQUIRED. H10: DEVICE EVALUATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WONT HOLD PATIENT DATA. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830572 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown