BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS AC ADAPTER

    MDR report key: 15538649 · Received October 4, 2022

    Report

    Report Number
    3012307300-2022-20915
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Report Date
    November 1, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    15019517126884
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    B5: ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM CUSTOMER ON 27-OCT-2022 AND ATTACHED TO COMPLAINT OBJECT: PRODUCT PART NUMBER: 21-0270-25, PRODUCT LOT NUMBER: 075W14200BF. UPDATED PRODUCT PART NUMBER AND LOT NUMBER IN COMPLAINT ATTRIBUTES. D4: DEVICE EXPIRATION DATE AND H4: DEVICE MANUFACTURING DATE NOT AVAILABLE - LOT NUMBER CAN NOT BE FOUND IN THE DATABASE. D4: UPDATED 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.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: DESCRIBE EVENT OR PROBLEM: UPDATED WITH ADDITIONAL INFORMATION RECEIVED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES ARE NOT REQUIRED. H10: NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING TO DATE. 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

    WHILE PERFORMING A REVIEW OF ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS NO PATIENT INVOLVEMENT, GIVEN THIS NEW INFORMATION A RISK ASSESSMENT WAS PERFORMED THERE WAS NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE (B)(4) IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH IT.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: IT WAS IDENTIFIED THAT SUPPLEMENTAL REPORT 003 WAS SUBMITTED IN ERROR AND THE REPORTED EVENT REMAINS A REPORTABLE MALFUNCTION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OCCURRED. SUPPLEMENTAL 003 SHOULD BE DISREGARDED. THE CORRECTED INFORMATION AND DEVICE EVALUATION ARE AS FOLLOWS: NO PRODUCT WAS RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THE DEVICE MANUFACTURING RECORDS ARE RETAINED BY THE SUPPLIER AT THEIR MANUFACTURING SITE AND ARE NOT READILY AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RAN OUT OF POWER AND DIED. UPON PLUGGING IN THE DEVICE, AND WAITING FOR 15 MINUTES, THE DEVICE DID NOT TURN ON. THERE HAS BEEN NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM A MANUFACTURER REP ON 20-OCT-2022 AND ATTACHED BY THE MANUFACTURER TO THE COMPLAINT OBJECT (INFORMATION AWARE DATE OF 10-OCT-2022 FROM CUSTOMER): ANESTHESIOLOGY DIRECTOR NOW THINKS THAT IT WAS THE POWER CORD THAT WAS NOT FUNCTIONING PROPERLY. WHEN SHE PLUGGED THE CORD IN THE BLUE LIGHT ON THE PUMP BESIDE WHERE THE POWER CORD INSERTS AND SHOWS THE PUMP IS CHARGING INITIALLY LIT UP BLUE BUT THEN FADED AWAY AND AFTER TRYING THE SAME CORD ON A DIFFERENT PUMP IT ALSO HAD THE SAME ISSUE. SHE HAS GIVEN THE CORD TO BIOMED. CUSTOMER WILL NOT BE SENDING BACK PUMP AT THIS TIME. INSTEAD, POWER CORD WILL BE RETURNED BY BIOMED IF AVAILABLE. REQUESTED POWER CORD REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2864030 CADD SOLIS AC ADAPTER PUMP, INFUSION FRN ST PAUL 2120 075W14200BF 15019517126884

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown