BEUDAMED
    FDA Adverse Event Other Summary report: N

    SETSOURCE IV TUBING CUSTOM SET

    MDR report key: 898696 · Received August 20, 2007

    Report

    Report Number
    2025816-2007-00017
    Event Type
    Other
    Date Received
    August 20, 2007
    Report Date
    June 14, 2007
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE ICU MEDICAL INC MFG Z0953 DEVICE SETS HAVE NOT BEEN IDENTIFIED AS MALFUNCTIONING AND/OR CAUSING OR CONTRIBUTING TO THE REPORTED EXPERIENCES. THE Z0953 DEVICE SETS CONTINUE TO BE USED THROUGHOUT THE HOSPITAL AND OUT-PATIENT FACILITIES PERFORMING AND MEETING ALL CLINICAL EXPECTATIONS. THE INVOLVED Z0953 DEVICE SETS HAVE NOT BEEN RETURNED TO THE MFR FOR ANALYSIS AND CONFIRMATION. CONFLICTING INFO REC'D REGARDING NUMBER OF INCIDENTS, PT'S REACTIONS, ETC. CAUSE OF THE INCIDENTS IS UNKNOWN AT THIS TIME. A REVIEW OF THE Z0953 MFR COMPLIANT DATABASE FOR THIS MODEL/LIST# IDENTIFIED NO ADD'L REPORTS.

    Description of Event or Problem · 1

    INFO REC'D. REPORTING AN INVESTIGATION OF ADVERSE PT REACTIONS AFTER INITIAL DELIVERY OF 1000ML. HOSPIRA LACTATED RINGERS ADMINISTERED VIA ICU MEDICAL MFG Z0953 100" 15 DROP PRIMARY CUSTOM DEVICE SETS. THE INITIAL INFO REPORTED THAT SINCE 2006, THERE HAVE BEEN APPROX 33 INCIDENTS. IT WAS ALSO REPORTED THAT EACH OF THE PTS RECOVERED/RETURNED TO BASELINE CONDITION <10-15 MINUTES AFTER INFUSIONS WERE DISCONTINUED. THERE WERE NO OBSERVED REPORTED Z0953 DEVICE SET FUNCTIONALITY/PERFORMANCE ISSUES ASSOCIATED WITH THESE EVENTS. THE FOLLOW-UP INVESTIGATION WITH THE REPORTING FACILITY RISK MGR STATES: SINCE JUNE 2006 DATA HAS BEEN COLLECTED BY THE FACILITY FOCUSING ON PTS RECEIVING SPECIFIC INFUSION THERAPIES EXPERIENCED A VARIETY OF "TRANSIENT SYMPTOMS". DEVICES, DRUGS, INVOLVED EQUIPMENT AND RELATED PRODUCTS ALONG WITH CLINICAL/PT NOTES AND RECORDS WERE COLLECTED, ANALYZED, REVIEWED AND CATEGORIZED TO DETERMINE POTENTIAL ROOT CAUSES. THE FACILITY INITIATED THIS INVESTIGATION WITH ADD'L TECHNICAL ASSISTANCE FROM STATE AND FEDERAL REGULATORY AGENCIES. ONLY 16 OF THESE INCIDENTS/PTS WERE AFTER DETAILED REVIEWS CLASSIFIED AS "CASE SYMPTOMS". HOWEVER, IN ALL THE EVENT/PT DATA COLLECTED AND STUDIED, THERE HAVE BEEN NO ADVERSE OUTCOMES, NO MEDICAL INTERVENTIONS BY FACILITY CLINICIANS/STAFF REQUIRED TO PRECLUDE SERIOUS, ADVERSE PT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETSOURCE IV TUBING CUSTOM SET PRIMARY IV CUSTOM SET FPA ICU MEDICAL, INC. Z0953 MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 YR AND OTHER LOTS NOT IDENTIFIED| 43-143-JT| LOT #41-178-JT| 46-050-JT| HOSPIRA LACTATED RINGERS| 44-125-JT