BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SPECTRUM

    MDR report key: 8199263 · Received December 27, 2018

    Report

    Report Number
    1820334-2018-03892
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    November 26, 2018
    Report Date
    April 25, 2019
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002237636
    PMA / PMN Number
    K081113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. CORRECTION: THE DEVICE WAS NOT RETURNED. INVESTIGATION EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A REVIEW OF ANOTHER COMPLAINT (PR245946) WITH A SIMILAR DEVICE AND FAILURE MODE WAS COMPLETED. THE PHYSICAL EXAMINATION IN THAT INVESTIGATION FOUND THAT SEVERAL LUMENS OF THE RETURNED DEVICES FLUSHED BROWNISH LIQUID. INVESTIGATORS COULD RECREATE THE REPORTED FAILURE MODE. IT WAS CONCLUDED THAT THE CAUSE COULD NOT BE DETERMINED. BECAUSE OF THE SIMILARITY OF THE FAILURE MODE BETWEEN THE REFERENCED COMPLAINT AND THE CURRENT COMPLAINT, IT IS POSSIBLE THAT THE TWO EVENTS HAVE A SIMILAR CAUSE. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DEVICE DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NONCONFORMANCES FOR LOT 8993401. A TOTAL OF THREE NONCONFORMANCES WERE FOUND FOR COMPLETE CATHETER LOT ONE IC8750194, OF WHICH TWO OF THESE WERE UNRELATED TO THIS EVENT. THE ADDITIONAL NONCONFORMANCE INVOLVED ONE DEVICE WITH ¿COATING IN I.D.¿ AND THE DEVICE WAS SUBSEQUENTLY SCRAPPED. COMPLETE CATHETER SUBASSEMBLY LOT TWO IC8659845 HAD THREE NONCONFORMANCES, OF WHICH TWO WERE FOUND TO BE UNRELATED TO THIS EVENT. THE OTHER NONCONFORMANCE INVOLVED TWO DEVICES WITH ¿250, COATING IN I.D.¿, OF WHICH ALL AFFECTED DEVICES WERE SCRAPPED. FINALLY, COMPLETE CATHETER LOT THREE IC8659849 RECORDED TWO NONCONFORMANCES THAT WERE FOUND TO BE UNRELATED TO THIS INCIDENT. IT SHOULD BE NOTED THAT THERE WAS ONE OTHER COMPLAINT ASSOCIATED WITH LOT 8993401, IN WHICH THE INVESTIGATION CONCLUDED THAT A CAUSE COULD NOT BE ESTABLISHED. THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: SUGGESTED CATHETER MAINTENANCE "THE ANTIMICROBIAL AGENTS MINOCYCLINE AND RIFAMPIN CONTAIN YELL/ORANGE PIGMENTS. SOME COLORATION OF THE SPECTRUM OR SPECTRUM GLIDE CATHETERS IS NORMAL." INSTRUCTIONS FOR USE " PREPARE THE CATHETER FOR INSERTION BY FLUSHING EACH OF THE LUMENS. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. MOST LIKELY THE DEVICE WAS FLUSHING OUT EXCESSIVE ABRM COATING. THE IFU STATES THAT, ¿SOME COLORATION OF THE COOK SPECTRUM CATHETERS IS NORMAL.¿ PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE 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 NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    BRAND NAME: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY. 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 WHILE FLUSHING THE CATHETER INCLUDED IN THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY, DISCOLORED FLUID WAS DISCOVERED. THE CATHETER WAS FLUSHED WITH NORMAL SALINE PRIOR TO INSERTION, AND THE USER OBSERVED BROWN FLUID UPON FLUSHING. THE CATHETER DID NOT MAKE PATIENT CONTACT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037932 COOK SPECTRUM FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC G23763 8993401 00827002237636

    Patients

    Seq Age Sex Outcome Treatment
    1