BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D 2SS CV

    MDR report key: 10304734 · Received July 21, 2020

    Report

    Report Number
    9616066-2020-02273
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 25, 2020
    Report Date
    June 29, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PUNCTURE DEVELOPED ON THE FLEXIBLE PIECE THAT SITS INSIDE OF THE ALARIS PUMP, CAUSING FLUID TO SQUIRT OUT. RECEIVED FROM THE CUSTOMER WAS ONE USED PRIMARY SET MODEL 2420-0007 LOT UNKNOWN. THE SET SAMPLE WAS INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. DURING VISUAL INSPECTION OF THE SET RECEIVED IT WAS OBSERVED THAT THE SILICONE SEGMENT PART NUMBER (P/N) 12088541 WAS COMPLETELY SEPARATED/TORN AWAY FROM THE UPPER FITMENT P/N TC10008721 WITH JAGGED APPEARANCES NOTED ON EACH CORNER OF THE SILICONE SEGMENT. THE RING RETAINER P/N 601316-000 AND A PIECE OF SILICONE WERE STILL PRESENT ON THE UPPER FITMENT. NO OTHER ANOMALIES WERE NOTED DURING VISUAL INSPECTION. FLUID WAS OBSERVED LEAKING FROM THE TEAR. FUNCTIONAL TESTING WAS NOT NECESSARY AS IT IS OBVIOUS THAT A LEAK WOULD OCCUR FROM THIS SEPARATION. DEVICE HISTORY RECORD COULD NOT BE PERFORMED ON MODEL 2420-0007 BECAUSE THE LOT # FOR THE SUSPECT SET WAS NOT PROVIDED. ALTHOUGH THE ROOT CAUSE OF THE SILICONE SEGMENT DAMAGE COULD NOT BE DEFINITIVELY DETERMINED, PREVIOUS INVESTIGATIONS HAVE SHOWN THAT THIS DAMAGE MAY BE A PRE-EXISTING CONDITION OF THE SILICONE RAW MATERIAL, OR CAN OCCUR DURING MANUFACTURING, SET LOADING OR AS A RESULT OF EXCESSIVE STRETCHING OR PULLING OF THE TUBING DURING USE. PUMP SEGMENT ISSUES ARE CURRENTLY BEING INVESTIGATED AND WILL BE ADDRESSED UNDER SYSTEMIC FAILURE INVESTIGATION FOR PUMP SEGMENT ((B)(4)). H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED LEAKAGE, UNDERINFUSION, AND DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EVENT DATE WAS (B)(6) 2020. ALARIS PUMP PRIMARY IV TUBING PLACED IN ALARIS PUMP OVERNIGHT AND INFUSING WITHOUT DIFFICULTY. IV TUBING SOMEHOW DEVELOPED A PUNCTURE ON THE FLEXIBLE PIECE THAT SITS INSIDE OF THE ALARIS PUMP, CAUSING FLUID TO SQUIRT OUT. THE MEDICATION INFUSING WAS A CONTINUOUS HEPARIN DRIP FOR ANTICOAGULATION. IT IS UNCLEAR HOW LONG THE FLUID WAS LEAKING AND HOW MUCH OF THE MEDICINE THE PATIENT RECEIVED. IT IS POSSIBLE THAT SHE RECEIVED LESS THAN THE ORDERED AMOUNT. A BREAK IN THE CLOSED SYSTEM CAN ALSO CAUSE AN INCREASED RISK OF INFECTION. THE FLUID WAS ON THE FLOOR, AND THE PATIENT COULD HAVE SLIPPED. SHE WAS A HIGH FALL RISK PATIENT WITH A SITTER AT THE BEDSIDE. THIS IS NOT THE FIRST TIME SIMILAR CONCERNS HAVE BEEN REPORTED WITH THE PRIMARY ALARIS TUBING. THIS IS THE 2420-0007 PRODUCT, BUT I DON¿T HAVE A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED LEAKAGE, UNDERINFUSION, AND DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EVENT DATE WAS (B)(6) 2020. ALARIS PUMP PRIMARY IV TUBING PLACED IN ALARIS PUMP OVERNIGHT AND INFUSING WITHOUT DIFFICULTY. IV TUBING SOMEHOW DEVELOPED A PUNCTURE ON THE FLEXIBLE PIECE THAT SITS INSIDE OF THE ALARIS PUMP, CAUSING FLUID TO SQUIRT OUT. THE MEDICATION INFUSING WAS A CONTINUOUS HEPARIN DRIP FOR ANTICOAGULATION. IT IS UNCLEAR HOW LONG THE FLUID WAS LEAKING AND HOW MUCH OF THE MEDICINE THE PATIENT RECEIVED. IT IS POSSIBLE THAT SHE RECEIVED LESS THAN THE ORDERED AMOUNT. A BREAK IN THE CLOSED SYSTEM CAN ALSO CAUSE AN INCREASED RISK OF INFECTION. THE FLUID WAS ON THE FLOOR, AND THE PATIENT COULD HAVE SLIPPED. SHE WAS A HIGH FALL RISK PATIENT WITH A SITTER AT THE BEDSIDE. THIS IS NOT THE FIRST TIME SIMILAR CONCERNS HAVE BEEN REPORTED WITH THE PRIMARY ALARIS TUBING. THIS IS THE 2420-0007 PRODUCT, BUT I DON¿T HAVE A LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764340 AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. UNKNOWN 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200625| 20200625