BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SPECTRUM

    MDR report key: 9272049 · Received November 4, 2019

    Report

    Report Number
    1820334-2019-02758
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 16, 2019
    Report Date
    December 20, 2019
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002478251
    PMA / PMN Number
    K081113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED PRODUCT WERE CONDUCTED DURING THE INVESTIGATION. ONE CVC DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. UPON VISUAL INSPECTION, CRACKS WERE NOTED ON THE STAMPS OF THE BLUE AND WHITE HUBS. BIOMATTER WAS PRESENT THROUGHOUT THE DEVICE. A FUNCTIONAL TEST CONFIRMED LEAKS ON BOTH THE BLUE AND WHITE HUBS. AT THIS TIME, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHRS FOR THE COMPLAINT LOT (9211207) AND ALL ASSOCIATED SUBASSEMBLY LOTS REVEALED NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOUND NO ADDITIONAL EVENTS ASSOCIATED WITH THE PROVIDED COMPLAINT LOT. DUE TO THIS INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT NON-CONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [C_T_ULMABRM_REV7] ¿SPECTRUM AND SPECTRUM GLIDE CENTRAL VENOUS CATHETERS,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: SUGGESTED LUMEN UTILIZATION: DOUBLE LUMEN ¿#1 DISTAL EXIT PORT (ENDHOLE) ¿ WHOLE BLOOD OR BLOOD PRODUCT DELIVERY AND SAMPLING; ANY SITUATION REQUIRING MORE FLOWRATE; CVP MONITORING; MEDICATION DELIVERY. IT IS STRONGLY RECOMMENDED THAT THIS LUMEN BE USED FOR ALL BLOOD SAMPLING. #2 PROXIMAL EXIT PORT ¿ MEDICATION DELIVERY; ACUTE HYPERALIMENTATION.¿ SUGGESTED CATHETER MAINTENANCE: ¿ANY UNUSED LUMENS SHOULD BE MAINTAINED WITH CONTINUOUS SALINE OR HEPARINIZED SALINE DRIP OR LOCKED WITH HEPARINIZED SALINE SOLUTION. HEPARIN-LOCKED LUMENS SHOULD BE REESTABLISHED AT LEAST EVERY 8 HOURS. BEFORE USING ANY LUMEN ALREADY LOCKED WITH HEPARIN, LUMEN SHOULD BE FLUSHED TWICE THE INDICATED LUMEN VOLUME USING NORMAL SALINE. LUMENS SHOULD BE FLUSHED WITH NORMAL SALINE BETWEEN ADMINISTRATIONS OF DIFFERENT INFUSATES. AFTER USE, LUMEN SHOULD AGAIN BE FLUSHED WITH TWICE THE INDICATED LUMEN VOLUME USING NORMAL SALINE BEFORE REESTABLISHING HEPARIN LOCK.¿ HOW SUPPLIED: ¿SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION STATING THAT THE FITTING OF THE DEVICE WAS CONNECTED TO AN "AUTOMATIC CHEMICAL ADDITION AND CONTROL SYSTEM" AND THAT SYSTEM IS NOT AVAILABLE FOR RETURN. THE DEVICE WAS LEFT IN PLACE FOUR HOURS AFTER THE PROCEDURE AND WAS LOCKED WITH A NEEDLELESS CLOSED SYSTEM.

    Additional Manufacturer Narrative · 1

    DEVICE NAME: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REGULAR WARD ROUND, THE BLUE AND WHITE PORT OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WAS FOUND TO BE LEAKING. NO PROBLEMS OCCURRED DURING THE RIGHT SIDE NECK PROCEDURE. THE PHYSICIAN INJECTED NIMODIPINE THROUGH THE BLUE PORT, AND FOUND THE BLUE AND WHITE PORTS TO BE LEAKING DURING ROUNDS. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AT THIS TIME. ADDITIONAL INFORMATION REGARDING EVENT AND DEVICE DETAILS HAVE BEEN REQUESTED, BUT HAVE NOT BEEN MADE AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066608 COOK SPECTRUM FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC G47825 9211207 00827002478251

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR