BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC

    MDR report key: 6178697 · Received December 15, 2016

    Report

    Report Number
    2025816-2016-00276
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 29, 2016
    Report Date
    December 21, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    PMA / PMN Number
    K052828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT LOT REVIEW: SUSPECT LOT# 3260702 CITED NO NLRS, MFD. 06/2016, NO EXCEPTION DOCUMENTS CITED. SUSPECT LOT# 3242279 CITED NO NLRS, MFD. 06/2016 NO EXCEPTION DOCUMENTS CITED. SUSPECT LOT# 3280831 CITED NO NLRS, MFD. 06/2016 NO EXCEPTION DOCUMENTS CITED. SUSPECT LOT# 3322362 CITED NO NLRS, MFD. 06/16 NO EXCEPTION DOCUMENTS CITED. SUSPECT LOT# 3273150 CITED NO NLRS, MFD. 06/2016 NO EXCEPTION DOCUMENTS CITED. VISUAL RECEIPT ANALYSIS: 12/15/2016 - RECEIVED THE FOLLOWING: TWO NEW ONE 011-46104-42, ARTERIAL SAFESET TRANSPAC IT W/3 ML RESERVOIR AND SINGLE NEEDLELESS VALVE, WITH VELCRO ARM STRAP, PATIENT MOUNT; LOT NUMBER 3183373 TWO NEW CODAN BC 2039N REF# 72.8067. FUNCTIONAL TESTING: OPENED BOTH NEW TRANSPACS. PULL TESTED BOTH OF THE SAFESET LINE TUBING TO FAILURE. UNIT 1 PEAK FORCE WAS 15.44 LBF AND UNIT 2 WAS 17.82 LBF. BOTH WELL EXCEEDED SPECIFICATION. FINAL ANALYSIS SUMMARY: THE REPORTED COMPLIANT OF SAFESET LINE FALLING APART COULD NOT BE CONFIRMED WITH THE NEW UNUSED UNIT. BOTH UNITS WERE PULL TESTED TO FAILURE AND EXCEEDED SPECIFICATION. NO USED UNITS WERE RETURNED FOR INVESTIGATION. ICU MEDICAL WILL CONTINUE TO MONITOR AND TREND THE FAILURE.

    Additional Manufacturer Narrative · 1

    SUSPECT LOT REVIEW: SUSPECT LOT# 3260702 CITED NO NLRS, MFD. 06/16, NO EXCEPTION DOCUMENTS CITED. SUSPECT LOT# 3242279 CITED NO NLRS, MFD. 06/16 NO EXCEPTION DOCUMENTS CITED. SUSPECT LOT# 3280831 CITED NO NLRS, MFD. 06/16 NO EXCEPTION DOCUMENTS CITED. SUSPECT LOT# 3322362 CITED NO NLRS, MFD. 06/16 NO EXCEPTION DOCUMENTS CITED. SUSPECT LOT# 3273150 CITED NO NLRS, MFD. 06/16 NO EXCEPTION DOCUMENTS CITED.

    Description of Event or Problem · 1

    COMPLAINT REGARDING ONE 011-46104-42, ARTERIAL SAFESET TRANSPAC IT W/3 ML RESERVOIR AND SINGLE NEEDLELESS VALVE, WITH VELCRO ARM STRAP, PATIENT MOUNT; LOT NUMBER IS UNKNOWN. REPORT STATES: SAFESET LINE FELL APART AT BONDED AREA. ONE OF THE FAULTY PRODUCTS WILL BE RETURNED. UNFORTUNATELY PACKAGING WAS DISCARDED, SO NOT SURE WHAT BATCH NUMBER. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    COMPLAINT REGARDING ONE 011-46104-42, ARTERIAL SAFESET¿ TRANSPAC® IT W/3 ML RESERVOIR AND SINGLE NEEDLELESS VALVE, WITH VELCRO ARM STRAP, PATIENT MOUNT; LOT NUMBER IS UNKNOWN. REPORT STATES: SAFESET LINE FELL APART AT BONDED AREA. ONE OF THE FAULTY PRODUCTS WILL BE RETURNED. UNFORTUNATELY PACKAGING WAS DISCARDED, SO NOT SURE WHAT BATCH NUMBER. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826819 TRANSPAC TRANSPAC DRS ICU MEDICAL, INC. 011-46104-42 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1