BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 14576213 · Received June 1, 2022

    Report

    Report Number
    MW5110055
    Event Type
    Injury
    Date Received
    June 1, 2022
    Report Date
    May 30, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS: SPOKE WITH PATIENT AND HER HUSBAND REGARDING PATIENT FEELING UNWELL. WHEN PATIENT WAS CHANGING HER CASSETTE, THE PUMP DISPLAYED THE MESSAGE NO DISPOSABLE, CLAMP TUBING. PATIENT STATES SHE IMMEDIATELY MADE ANOTHER CASSETTE AND ATTACHED ON THE BACK UP PUMP. SHE WAS ABLE TO CONTINUE INFUSION WITHOUT DISRUPTION. DURING TROUBLESHOOTING WITH PUMP, PATIENT STATES SHE "BOLUS-D" AND FELT UNWELL AFTER. UNKNOWN HOW SHE BOLUS-D HERSELF. ADVISED PATIENT TO TAKE HER BLOOD PRESSURE AND IT WAS 91/48. CONFIRMED PUMP RATE TO BE 44ML/24HR ON PUMP. WAITED ON THE LINE AND ADVISED PATIENT TO TAKE ANOTHER BLOOD PRESSURE READING AND RETURNED TO NORMAL 107/64 AFTER 15 MINUTES. ADVISED PATIENT TO MONITOR BLOOD PRESSURE. AT THE END OF THE CALL, PATIENT STATES HER BREATHING IS FINE AND FEELS STABLE. MALFUNCTION PUMP SN# (B)(4). CASSETTE LOT# 4163625. PATIENT REQUESTS URGENT SHIPMENT OF BACKUP PUMP AND PUMP RETURN BOX. NO OTHER INFORMATION KNOWN. DID THE PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? NO; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? YES; PT UNKNOWINGLY INFUSED BOLUS OF MEDICATION. IF YES, WAS ANY MEDICAL INTERVENTION PROVIDED? NO; IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION? NO; DID WE REPLACE THE CASSETTE? NO; DID THE PT HAVE ADD'L CASSETTES THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23704 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 6400 4163625
    23705 CADD PUMP PUMP INFUSION LHI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female