BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESET TRANSPAC IV

    MDR report key: 6129185 · Received November 28, 2016

    Report

    Report Number
    2025816-2016-00264
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    October 22, 2016
    Report Date
    December 7, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: SUSPECT LOT # 3145191 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MAY 2016 CITING NO EXCEPTION DOCUMENTS.

    Additional Manufacturer Narrative · 1

    LOT REVIEW: SUSPECT LOT # 3145191 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MAY 2016 CITING NO EXCEPTION DOCUMENTS. RECEIPT ANALYSIS: 11/7/2016 - RECEIVED THE FOLLOWING: TWO USED 011-46103-25, SAFESET TRANSPAC® IV W/03ML RESERVOIR AND SINGLE NEEDLESS VALVE, PATIENT MOUNT, SUSPECT LOT# 3253161, 2967619, 3303995, 3155470, 3145191, 3066768, 3050729, 3040681 AND 3076437. ONE NEW 011-46103-25, SAFESET TRANSPAC® IV W/03ML RESERVOIR AND SINGLE NEEDLESS VALVE, PATIENT MOUNT, LOT# 3066768. ONE NEW 011-46103-25, SAFESET TRANSPAC® IV W/03ML RESERVOIR AND SINGLE NEEDLESS VALVE, PATIENT MOUNT, LOT# 3050729. ONE NEW 011-46103-25, SAFESET TRANSPAC® IV W/03ML RESERVOIR AND SINGLE NEEDLESS VALVE, PATIENT MOUNT, LOT# 3040681. ONE NEW 011-46103-25, SAFESET TRANSPAC® IV W/03ML RESERVOIR AND SINGLE NEEDLESS VALVE, PATIENT MOUNT, LOT# 2967619. ONE NEW 011-46103-25, SAFESET TRANSPAC® IV W/03ML RESERVOIR AND SINGLE NEEDLESS VALVE, PATIENT MOUNT, LOT# 3076437. TWO NEW 011-46103-25, SAFESET TRANSPAC® IV W/03ML RESERVOIR AND SINGLE NEEDLESS VALVE, PATIENT MOUNT, LOT# 3253161. TWO NEW 011-46103-25, SAFESET TRANSPAC® IV W/03ML RESERVOIR AND SINGLE NEEDLESS VALVE, PATIENT MOUNT, LOT# 3145191. TWO NEW 011-46103-25, SAFESET TRANSPAC® IV W/03ML RESERVOIR AND SINGLE NEEDLESS VALVE, PATIENT MOUNT, LOT# 3155470. THE TWO USED SAMPLES WAS CONFIRMED TO LEAK AT THE BONDING SITE OF RED STRIPE TUBING AND THE SAFESET SYRINGE. FUNCTIONAL TESTING: EACH UNIT WAS VISUALLY EXAMINED. THE NEW UNITS WERE OPENED AND THE TUBING WAS BENT STRAIGHT AND TWISTED 180 DEGREES IN BOTH DIRECTIONS. ONE OF THE NEW UNITS WAS OBSERVED TO CRACK IDENTICAL TO THE TWO USED SAMPLES. FINAL ANALYSIS SUMMARY: THE REPORTED COMPLIANT OF AIR GETTING IN LINE WAS CONFIRMED FROM CRACKED TUBING. THE ROOT CAUSE OF THE FAILURE IS FROM A SOLVENT ISSUE. ICU THROUGH CONTINUOUS CORRECTIVE AND PREVENTATIVE ACTIONS ARE REVIEWING THE PROCESS AND MAKING THE NECESSARY IMPROVEMENTS TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING WITH ONE, 011-46103-25, SAFESET TRANSPAC® IV W/03ML RESERVOIR AND SINGLE NEEDLESS VALVE, PATIENT MOUNT, VARIOUS SUSPECT LOT#"S (MFD. 01/2015 TO 05/2016). THE REPORT STATES; AS MENTIONED THE CLIENT HAS REMOVED THE AFFECTED PART OF THE 011-46103-25 SAFESET SYRINGE AND PUT AN ADD ON INTO THE SET SO THEY COULD CONTINUE USING THE TRANSDUCER, HENCE ONLY HAVING PART OF THE SET. THEY WERE UNABLE TO PROVIDE AN ACCURATE LOT NUMBER BUT ALL LOT#'S THAT WERE REMOVED HAVE BEEN PROVIDED AND SOME SENT TO YOU FOR TESTING. UNSURE AS TO THE EXACT POSITION OF THE LEAK ON BOTH SETS AND WAS ONLY TOLD THAT THEY WERE GETTING AIR IN THE LINE FROM THE SAFESET SYRINGE WHEN TRYING TO SAMPLE. THERE WAS NO ADVERSE PATIENT OUTCOMES IDENTIFIED AS THE LEAK WAS SPOTTED AND SWAPPED OUT IMMEDIATELY WITH NO DELAYS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING WITH ONE, 011-46103-25, SAFESET TRANSPAC® IV W/03ML RESERVOIR AND SINGLE NEEDLESS VALVE, PATIENT MOUNT, VARIOUS SUSPECT LOT#"S (MFD. 01/15 TO 05/16). THE REPORT STATES; AS MENTIONED THE CLIENT HAS REMOVED THE AFFECTED PART OF THE 011-46103-25 SAFESET SYRINGE AND PUT AN ADD ON INTO THE SET SO THEY COULD CONTINUE USING THE TRANSDUCER, HENCE ONLY HAVING PART OF THE SET. THEY WERE UNABLE TO PROVIDE AN ACCURATE LOT NUMBER BUT ALL LOT#'S THAT WERE REMOVED HAVE BEEN PROVIDED AND SOME SENT TO YOU FOR TESTING. UNSURE AS TO THE EXACT POSITION OF THE LEAK ON BOTH SETS AND WAS ONLY TOLD THAT THEY WERE GETTING AIR IN THE LINE FROM THE SAFESET SYRINGE WHEN TRYING TO SAMPLE. THERE WAS NO ADVERSE PATIENT OUTCOMES IDENTIFIED AS THE LEAK WAS SPOTTED AND SWAPPED OUT IMMEDIATELY WITH NO DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781388 SAFESET TRANSPAC IV TRANSPAC DRS ICU MEDICAL, INC. 011-46103-25 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1