BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SPECTRUM

    MDR report key: 9763210 · Received February 27, 2020

    Report

    Report Number
    1820334-2020-00480
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    January 22, 2020
    Report Date
    April 13, 2020
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002478299
    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 UNCHANGED, UNKNOWN OR UNAVAILABLE. D10 PRODUCT RECEIVED ON: 02MAR2020. INVESTIGATION EVALUATION. IT WAS REPORTED THAT A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET (C-UTLM-701J-RSC-ABRM-HC-RD) FROM LOT 9510505 BECAME OCCLUDED SEVEN DAYS AFTER PLACEMENT. ALL LUMENS WERE FILLED WITH SALINE PRIOR TO INTRODUCTION INTO THE BODY. NUTRITION MEDICINE WAS BEING DELIVERED THROUGH THE DEVICE, AND UNUSED LUMENS WERE FLUSHED AND LOCKED WITH SALINE. COOK BECAME AWARE OF THIS EVENT ON (B)(6) 2020 UPON BEING NOTIFIED BY A DOCTOR FROM NATIONAL CHENG KUNG UNIVERSITY HOSPITAL. THE PATIENT REPORTEDLY EXPERIENCED NO ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. A REVIEW OF THE COMPLAINT HISTORY AND DEVICE HISTORY RECORD, AS WELL AS A FUNCTIONAL TEST OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS RETURNED WITH THE DISTAL TIP CUT OFF. A COOK MICROCLAVE WAS ATTACHED TO THE WHITE HUB, WHILE TWO THIRD PARTY MICROCLAVES WERE ATTACHED TO THE RED AND BLUE HUBS. THE DEVICE EXAMINATION FOUND THAT ALL THREE HUBS WERE ABLE TO BE FLUSHED WITHOUT ISSUE, AND BIOLOGICAL MATTER WAS FLUSHED OUT OF THE BLUE LUMEN. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD FOUND THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF THE DESIGN HISTORY FILE FOUND THAT THE RISKS ASSOCIATED WITH THE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NONCONFORMANCES OR ADDITIONAL COMPLAINTS ASSOCIATED WITH THIS DEVICE LOT. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. A REVIEW OF THE PRODUCT LABELING FOR THE DEVICE WAS COMPLETED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING INSTRUCTIONS RELATED TO THE REPORTED FAILURE MODE: SUGGESTED CATHETER MAINTENANCE TO PREVENT CLOTTING OR POSSIBILITY OF AIR EMBOLUS, THE DOUBLE-LUMEN¿S #2 LUMEN, THE TRIPLE-LUMEN¿S #2 AND #2 LUMENS, AND THE FIVE-LUMEN¿S #2, #3, #4, AND #5 LUMENS SHOULD BE FILLED WITH SALINE SOLUTION OR HEPARINIZED SALINE SOLUTION (100 UNITS OF HEPARIN PER ML OF SALINE IS USUALLY ADEQUATE), DEPENDING ON INSTITUTIONAL PROTOCOL, PRIOR TO CATHETER INTRODUCTION. ANY UNUSED LUMENS SHOULD BE MAINTAINED WITH CONTINUOUS SALINE OR HEPARINIZED SALINE DRIP OR LOCKED WITH HEPARINIZED SALINE SOLUTION. BEFORE USING ANY LUMEN ALREADY LOCKED WITH HEPARIN, LUMEN SHOULD BE FLUSHED WITH 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. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, THE CAUSE COULD BE ESTABLISHED AS AN ADVERSE EVENT RELATED TO THE PATIENT CONDITION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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

    NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    BRAND 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 A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER WAS FOUND TO BE OCCLUDED DURING INFUSION. THE DEVICE WAS BEING USED IN THE LEFT FEMORAL VEIN. IT WAS REPORTED "THE PHYSICIAN FELT RESISTANCE DURING THE PROCEDURE". ALL LUMENS WERE REPORTED TO BE FILLED WITH SALINE BEFORE INTRODUCTION INTO THE BODY. NUTRITION MEDICATIONS WERE BEING DELIVERED THROUGH THE DEVICE. SALINE WAS USED TO FLUSH THE UNUSED LUMEN AND LOCK THE DEVICE. THE PATIENT PREVIOUSLY HAD BRAIN SURGERY. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224931 COOK SPECTRUM FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC NA 9510505 00827002478299

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR