BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS

    MDR report key: 6249259 · Received January 13, 2017

    Report

    Report Number
    2025816-2017-00006
    Event Type
    Malfunction
    Date Received
    January 13, 2017
    Date of Event
    December 12, 2016
    Report Date
    January 17, 2017
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K082806
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT LOT REVIEW: A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 66-747-SL (MFG. DATE 08/2016) SHOWS (B)(4) UNITS WERE MFGD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. RECEIPT ANALYSIS: 1/12/2017 - RECEIVED THE FOLLOWING: 18 NEW 20130-01, SPINNING SPIROS CLOSED MALE LUER, RED CAP; LOT# 66-747-SL. ONE LABEL FOR SPINNING SPIROS 20130-01 LOT# 68-789-HE. THREE USED SPINNING SPIROS LOT# UNKNOWN. TWO USED BD 20ML SYRINGE. ONE USED MONOJECT 12ML SYRINGE. THE SYRINGES WERE EACH CONNECTED TO A SPINNING SPIROS. FUNCTIONAL TESTING: ONE OF THE RETURNED USED 20130-01 SPINNING SPIROS WAS CONNECTED TO A 20ML LUER LOCK SYRINGE WITH A LABEL ON IT AND SOME SLIGHT DAMAGE AT THE LEADING END OF THE MALE LUER THREADS. THE THREADED CONNECTION INTERFACE WAS NOT CORRECT WITH THIS SAMPLE. IT APPEARED THAT EITHER AN ATTEMPT WAS MADE TO RECONNECT THE 20130-01 SPINNING SPIROS TO THE SYRINGE AFTER THE SPIN FEATURE HAD BEEN ACTIVATED, OR THE CONNECTION WAS ATTEMPTED BY PUSHING THE 20130-01 SPINNING SPIROS ONTO THE SYRINGE WHILE ROTATING THUS ACTIVATING THE SPIN FEATURE WITHOUT THE THREADS ENGAGED. THE TWO USED 20130-01 SPINNING SPIROS CONNECTED TO THE OTHER TWO SYRINGES HAD RESIDUAL AND DISCONNECT TORQUE FORCES THAT MET EXPECTATIONS. FINAL ANALYSIS SUMMARY: ONE OF THE RETURNED USED 20130-01 SPINNING SPIROS CONNECTED TO A 12ML LUER LOCK SYRINGE WITH A LABEL WAS NOT WELL CONNECTED WHEN EVALUATED. THE LUER THREADS WERE NOT ENGAGED PROPERLY. IT IS NOT KNOWN THE EXACT CAUSE OF THE INADEQUATE THREAD CONNECTION. THE OTHER TWO USED 20130-01 SPINNING SPIROS CONNECTED TO LUER LOCK SYRINGES HAD LOW RESIDUAL TORQUE AND DISCONNECT TORQUE MEASURED THAT WOULD NOT RESULT IN PREMATURE DISCONNECT DURING NORMAL USE. EACH OF THE NEW/UNUSED 20130-01 SPINNING SPIROS HAD THE CONNECT, RESIDUAL, AND DISCONNECT TORQUE VALUES MEASURED WHEN CONNECTING TO A LUER LOCK SYRINGE. THERE WAS NO INSTANCE THAT WOULD HAVE RESULTED IN A PREMATURE DISCONNECT. ICU MEDICAL WILL CONTINUE TO MONITOR AND TREND.

    Additional Manufacturer Narrative · 1

    SUSPECT LOT REVIEW: A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 66-747-SL (MFG. DATE 08/2016) SHOWS (B)(4) UNITS WERE MFGD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS.

    Description of Event or Problem · 1

    COMPLAINT REC'D REGARDING TWO (2) 20130-01, SPINNING SPIROS CLOSED MALE LUER, RED CAP; LOT# UNKNOWN. THE REPORT STATES, CYTARABINE SYRINGE: TWO INCIDENTS OF SPINNING SPIROS COMING DISCONNECTED FROM THE SYRINGE DURING THE PATIENT INFUSION. UNPROTECTED CHEMO EXPOSURE REPORTED BUT NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    COMPLAINT REC'D REGARDING TWO (2) 20130-01, SPINNING SPIROS CLOSED MALE LUER, RED CAP; LOT# UNKNOWN. THE REPORT STATES, CYTARABINE SYRINGE: TWO INCIDENTS OF SPINNING SPIROS COMING DISCONNECTED FROM THE SYRINGE DURING THE PATIENT INFUSION. UNPROTECTED CHEMO EXPOSURE REPORTED BUT NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32988 SPINNING SPIROS SPINNING PIROS FPA ICU MEDICAL, INC. 20130-01 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1