BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO

    MDR report key: 6253122 · Received January 16, 2017

    Report

    Report Number
    2025816-2017-00007
    Event Type
    Malfunction
    Date Received
    January 16, 2017
    Date of Event
    December 16, 2016
    Report Date
    January 27, 2017
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    Removal / Correction Number
    2025816-09/01/2016-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT REPORTED LOT NUMBER(S): A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3293926 (MFG. DATE 07/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3286571 (MFG. DATE 07/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3275467 (MFG. DATE 06/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED. CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3261516 (MFG. DATE 05/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3239848 (MFG. DATE 04/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3246196 (MFG. DATE 04/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3244023 (MFG. DATE 04/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3235880 (MFG. DATE 04/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3195861 (MFG. DATE 03/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3116029 (MFG. DATE 09/2015) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3286571 (MFG. DATE 07/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. VISUAL ANALYSIS: RECEIVED 13 USED D1000 TEGO CONNECTORS. SUSPECT REPORTED LOT# LOT NUMBER(S): 3286571, 3275467*, 3261516*, 3239848, 3246196*, 3244023*, 3235880, 3195861, 3116029, 3286571, 3293926 NO MATING DEVICES WERE RETURNED. FOURTEGOS WERE OBSERVED TO HAVE DAMAGE TO THE SILICONE. THREE TEGOS DID NOT APPEAR TO HAVE EXTERNAL DAMAGE. SIX TEGOS WERE OBSERVED TO HAVE BLOOD UNDER THE SILICONE. FUNCTIONAL TESTING: THREE USED D1000 TEGO WERE RETURNED WITHOUT ANY OBSERVABLE DAMAGE OR ANOMALIES. THREE USED D1000 TEGO WERE RETURNED WITH VARYING AMOUNTS OF SEAL TEARING, AND ONE WITH A DOMED VALVE. SIX USED D1000 TEGO WERE RETURNED WITH BLOOD BETWEEN THE SEAL AND THE BODY. THREE USED D1000 TEGO WERE RETURNED WITHOUT ANY OBSERVABLE DAMAGE OR ANOMALIES WERE PRESSURE TESTED WITH NO LEAKAGE WAS OBSERVED. THE THREE UNITS WERE PRESSURE TESTED FOR MAIN SEAL INTEGRITY WITH NO LEAKAGE OBSERVED. THE THREE USED D1000 TEGO THAT WERE RETURNED WITH VARYING AMOUNTS OF SEAL TEARING WERE PRESSURE TESTED AND NO LEAKAGE WAS OBSERVED. THE THREE UNITS WERE PRESSURE TESTED FOR MAIN SEAL INTEGRITY AND NO LEAKAGE OBSERVED. THE ONE D1000 TEGO RETURNED WITH A DOMED VALVE WAS PRESSURE TESTED AND LEAKED. THE D1000 TEGO WAS PARTIALLY DISASSEMBLED AND FOUND TO HAVE THE VALVE DISPLACED. THE VALVE WAS POSITIONED ON TOP OF THE BODY POST RESULTING IN A DOMED VALVE. THERE WAS EVIDENCE OF ADHESIVE APPLIED NEAR THE SHOULDERS OF THE VALVE THAT PREVENTS DOMING, BUT THE ADHESIVE BOND HAD BEEN TORN ON BOTH SIDES OF THE ASSEMBLY. THE SIX USED D1000 TEGO THAT WERE RETURNED WITH BLOOD BETWEEN THE SEAL AND THE BODY WERE PRESSURE TESTED FOR MAIN SEAL INTEGRITY. ALL SIX FAILED. FINAL SUMMARY: THE COMPLAINT OF D1000 TEGO SEAL TEARING WAS CONFIRMED WITH THREE OF THE RETURNED SAMPLES. THE SAMPLES HAD VISIBLE TEARING NEAR THE TOP RIM AND ADJACENT TO THE THREAD POSTS. HOW THE SEAL TEARING OCCURRED IS NOT KNOWN, HOWEVER, THIS TYPE OF DAMAGE CAN BE CAUSED WHEN A SYRINGE IS OVER TIGHTENED AND CONTINUED CONNECTION ROTATIONS RESULTS IN DAMAGE. NO MATING DEVICES WERE RETURNED TO EVALUATE WITH THE DAMAGED D1000 TEGO. A SINGLE D1000 TEGO WAS RETURNED WITH A DOMED VALVE. THERE WAS EVIDENCE OF ADHESIVE ON THE ASSEMBLY THAT WOULD PREVENT VALVE DOMING, BUT THE ADHESIVE HAD BEEN TORN. IT IS NOT KNOWN IF THE D1000 TEGO WAS DISASSEMBLED PRIOR TO RECEIVING FOR INVESTIGATION OR IF THE ADHESIVE ANCHOR WAS TORN AT SOME OTHER PLACE AND TIME. THE COMPLAINT OF D1000 TEGO BLOOD LEAKAGE WAS CONFIRMED WITH SIX OF THE RETURNED CONNECTORS. THE LEAKAGE WAS THE RESULT OF DAMAGE TO THE ONE PIECE SEAL AT THE MAIN SEAL INTERFACE WITH THE BODY. ENGINEERING EFFORTS DID IDENTIFY COMPONENT/MOLDING ANOMALY THAT MAY HAVE CAUSED OR CONTRIBUTED TO A SEAL MISALIGNMENT. THIS CONDITION COULD RESULT IN INTERNAL LEAKAGE. A DETAILED ANALYSIS OF THE TEGO DESIGN, MATERIALS, MANUFACTURING AND INSPECTION PROCESSES AND EQUIPMENT WAS PERFORMED. THE DATA AND ENGINEERING EFFORTS IDENTIFIED THE SEAL COMPONENT ANOMALY WAS ATTRIBUTABLE TO THE MANUFACTURING/MOLDING OPERATION DUE TO A CAVITY CORE PIN (EDGE). CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED, QUALIFIED AND IMPLEMENTED. ICU MEDICAL WILL CONTINUE TO MONITOR AND TREND.

    Additional Manufacturer Narrative · 1

    SUSPECT REPORTED LOT NUMBER(S): A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3293926 (MFG. DATE 07/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3286571 (MFG. DATE 07/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3275467 (MFG. DATE 06/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED. CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3261516 (MFG. DATE 05/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3239848 (MFG. DATE 04/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3246196 (MFG. DATE 04/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3244023 (MFG. DATE 04/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3235880 (MFG. DATE 04/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3195861 (MFG. DATE 03/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3116029 (MFG. DATE 09/2015) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR LOT# 3286571 (MFG. DATE 07/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING MULTIPLE TEGO FAILURES NOTED SINCE JUNE 2016 SPANNING MULTIPLE LOTS. THE PROBLEMS REPORTED: TORN MEMBRANES (WITH SOME DETECTED PRIOR TO USE), BLOOD LEAKS, AIR IN LINES AND INNER VALVE FAILURES. NO CHANGES TO HABITUAL TECHNIQUE OR MATING DEVICES. PROBLEMS ARE CAUSING DELAYS AND BACKLOGS WITH TREATMENT SCHEDULES. ONE PATIENT SUFFERED SIGNIFICANT BLOOD LOSS DUE TO A LEAKING TEGO DURING TREATMENT WHICH WAS MASKED BY HER CLOTHING ; PATIENT HAD TO HAVE DIALYSIS INTERRUPTED AND BE MONITORED AD BLOODS DRAWN TO VERIFY HEMOGLOBIN LEVELS. PATIENT MADE UNEVENTFUL RECOVERY WITH RETURN TO BASELINE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING MULTIPLE TEGO FAILURES NOTED SINCE (B)(6) 2016 SPANNING MULTIPLE LOTS. THE PROBLEMS REPORTED: TORN MEMBRANES (WITH SOME DETECTED PRIOR TO USE), BLOOD LEAKS, AIR IN LINES AND INNER VALVE FAILURES. NO CHANGES TO HABITUAL TECHNIQUE OR MATING DEVICES. PROBLEMS ARE CAUSING DELAYS AND BACKLOGS WITH TREATMENT SCHEDULES. ONE PATIENT SUFFERED SIGNIFICANT BLOOD LOSS DUE TO A LEAKING TEGO DURING TREATMENT WHICH WAS MASKED BY HER CLOTHING ; PATIENT HAD TO HAVE DIALYSIS INTERRUPTED AND BE MONITORED AD BLOODS DRAWN TO VERIFY HEMOGLOBIN LEVELS. PATIENT MADE UNEVENTFUL RECOVERY WITH RETURN TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36132 TEGO TEGO FPA ICU MEDICAL, INC. D1000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1