BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOFINE ORBIT

    MDR report key: 2911215 · Received December 14, 2012

    Report

    Report Number
    2025816-2011-00104
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    August 10, 2011
    Report Date
    August 30, 2011
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION: ONE (1) USED PARTIAL YP2480 WAS RETURNED. VISUAL INSPECTION OF THE RETURNED YP2480 CONFIRMED THE REPORTED COMPONENT BREAKAGE. MICROSCOPIC ANALYSIS RECORDED THE SHANK OF THE NEEDLE WAS VISIBLE WITHIN THE BOND AREA OF THE ORBIT BASE, THUS CONCLUDING THAT THE NEEDLE DID NOT PULL FREE FROM THE BOND JOINT. BASED ON THE ENGINEERING EVALUATIONS, THE YP2480 NEEDLE COMPONENT WAS SHEARED OFF DUE TO SOME REPETITIVE OR SINGULAR LATERAL FORCE ON THE NEEDLE. RECORD ANALYSIS: A REVIEW OF THE MANUFACTURING LOT DATABASE FOR LOT# 1998197 (MANUFACTURE DATE 10/2010) SHOWS 900 UNITS WERE MANUFACTURED, TESTED, INSPECTED, AND RELEASED. A THREE (3) YEAR REVIEW OF THE MFR'S COMPLAINT DATABASE FOR THIS LIST NUMBER/LOT NUMBER AND SIMILAR PRODUCT ISSUE RECORDED NO ADD'L REPORTS. CONCLUSION: THE EXACT CAUSE OF THE REPORTED PRODUCT EXPERIENCE APPEARS TO BE A RESULT OF USAGE/UNINTENDED FORCE.

    Description of Event or Problem · 1

    INTERNATIONAL ((B)(6)) COMPLAINT RECEIVED REPORTING COMPONENT BREAKAGE INCIDENT INVOLVING ONE (1) YP2480 ROTOFINE ORBIT DEVICE, LOT# 1998197. IT WAS REPORTED "ON (B)(6), NEW "KATHETER" APPLIED ON LEG. AFTER 1.5 DAYS, THE H/C PT NOTICED A BROKEN OR LOOSE CANNULA PORTION WAS EMBEDDED INTO THE LEG". THE PT SOUGHT MEDICAL ATTENTION/TREATMENT AND RETURNED TO BASELINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTOFINE ORBIT CATHETER FPA ICU MEDICAL INC. YP2480 1998197

    Patients

    Seq Age Sex Outcome Treatment
    1 INFUSION PUMP