BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD S

    MDR report key: 15254800 · Received August 18, 2022

    Report

    Report Number
    3012307300-2022-15624
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Report Date
    December 2, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 IF ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. OPERATOR OF DEVICE IS UNKNOWN. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER: UPDATED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: A SAMPLE WAS RETURNED TO MANUFACTURING FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE TAMPER SEAL AND BATTERY DOOR WERE MISSING UPON RECEIPT. NO ERROR CODES WERE FOUND IN THE EHL (EVENT HISTORY LOG). THE CUSTOMER REPORTED ISSUE WAS DUPLICATED DURING THE INVESTIGATION AS, WHEN PRIMING, THE MOTOR SOUNDED DISTORTED, AND THE HUB GEAR WAS FOUND TO BE LOOSE. ROOT CAUSE OF THE REPORTED ISSUE IS UNKNOWN, BUT A LOOSE GEAR HUB WAS DETECTED. RE-SECURED THE HUB GEAR IN PLACE AND REPLACED THE MISSING BATTERY DOOR. A NONCONFORMANCE REPORT (NCR) WAS CREATED TO ADDRESS THE INCORRECT/NO CASSETTE/DISPOSABLE DETECTED ISSUE. REVIEWED THE DEVICE HISTORY RECORD DHR FOR JOB 4191093 WHICH INCLUDES THE REPORTED SERIAL NUMBER. THERE WAS NO EVIDENCE OF ANY ISSUES WITH THIS DEVICE DURING MANUFACTURING, BUT THERE WAS A LOOSE HUB GEAR ON SERIAL NUMBER (B)(6). THE HUB GEAR COMING LOOSE IS LIKELY A MANUFACTURING ISSUE WITH EITHER NOT APPLYING LOCTITE PROPERLY OR NOT SECURING THE SCREW PROPERLY. AN EMAIL WAS SENT TO MANUFACTURING TO REVIEW THIS ISSUE WITH THEIR TEAM. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE PREVIOUSLY.

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION RECEIVED ON 06-SEP-2022 VIA EMAIL AND ATTACHED IN COMPLAINT OBJECT: THERE WAS NO PATIENT OR TECHNICIAN INVOLVEMENT WAS INDICATED AT THE TIME THE PUMP WAS RECEIVED AT OUR FACILITY FOR REPAIR. ALL ISSUES FOUND WITH THIS DEVICE WERE FOUND DURING TESTING AT OUR FACILITY. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. 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., CORRECTED DATA: D4: CORRECTION: MODEL NUMBER: 2120.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CASSETTE ISSUE ERROR HAD OCCURRED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2905628 CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD S PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown