BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 1820575 · Received August 31, 2010

    Report

    Report Number
    6000001-2010-02888
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 12, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: FIFTY-NINE UNUSED COMPANION SAMPLES FROM A DIFFERENT LOT (R10E26051) WERE RECEIVED FOR EVALUATION. THE TESTING/EVALUATION OF THE RETURNED SAMPLES DID NOT CONFIRM THE NO FLOW/RESTRICTED FLOW AS REPORTED. A BATCH REVIEW WAS PERFORMED ON THE LOT REPORTED TO BE INVOLVED (R10F09089), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. A LABEL REVIEW OF PRODUCT CODE 2C8537 WAS CONDUCTED. ALTHOUGH THE LABEL DOES NOT CONTAIN WARNINGS SPECIFIC TO THE REPORTED ISSUE, THE LABEL CONTAINS THE APPROPRIATE WARNINGS, CAUTIONS AND DIRECTIONS FOR USE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLES RECEIVED FOR EVALUATION ARE NOT FROM THE SAME LOT NUMBER, WRITER CONTACTED THE CUSTOMER ON 09/16/2010, WHO INDICATED THAT WHEN THIS EVENT OCCURRED, SHE JUST PULLED PRODUCT FROM HER STOCK TO RETURN TO BAXTER FOR EVALUATION. THE LOT NUMBER PROVIDED FOR THIS COMPLAINT IS CORRECT BUT THE PRODUCT RETURNED MAY NOT HAVE BEEN FROM THE SAME LOT NUMBER. ON 10/01/2010, THE CUSTOMER ALSO PROVIDED CLARIFICATION OF THE DEFECT SHE IS REPORTING. THE CUSTOMER INDICATED THAT AN EMERGENT DRUG (ATROPINE) NEEDLE WAS ATTACHED TO THE SETUP AND WHEN ANOTHER PLASTIC PIECE WAS APPLIED TO GO OVER THE NEEDLE TO CREATE A NEEDLESS SYSTEM, THERE WAS A LOT OF RESISTANCE FROM THE LUER AND THE MEDICATION DID NOT FLOW, AND INSTEAD LEAKED OUT AROUND THEIR SETUP. NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).SAMPLES HAVE BEEN REPORTED AS BEING AVAILABLE. UPON COMPLETION OF THE INVESTIGATION, A MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THEIR BAXTER SALES REPRESENTATIVE (BSR) ONE (1) CLEARLINK CONTINU-FLO SOLUTION SET IN WHICH A NO FLOW WAS DETECTED WHEN LURED TO AN HOSPIRA ATROPINE PREFILLED SYRINGE DURING PATIENT USE. THE PATIENT'S BLOOD PRESSURE DROPPED AND THE CLINICIAN ATTEMPTED TO INFUSE A HOSPIRA ATROPINE PREFILLED SYRINGE TO BRING THE BLOOD PRESSURE LEVELS BACK TO A STABLE STATE. THE NURSE TRIED ALL THREE CLEARLINK PORTS AND NONE OF THEM WOULD ALLOW THE ATROPINE TO INFUSE. A BSR VISITED THE FACILITY ON 08/17/2010 AND CONFIRMED THE REPORTED CONDITION. THE BSR INDICATED THAT THERE IS A LOT OF RESISTANCE FROM THE LUER AND IT IS VERY DIFFICULT TO ACCESS. THE BSR INDICATED THAT THE PATIENT'S HEART RATE HAD DROPPED TO 30. THIS OCCURRED POST ANESTHESIA AND THE CUSTOMER CONFIRMED THAT THE PATIENT IS NOW IN GOOD CONDITION. ALTHOUGH THE ATROPINE COULD NOT BE INFUSED THROUGH THE Y-SITE, IT WAS DRAWN OUT OF THE PREFILLED SYRINGE AND INJECTED INTO THE PATIENT. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER ON 08/20/2010: THE EVENT OCCURRED ON (B)(6) 2010 WITH A (B)(6) MALE PATIENT POST ORTHOPEDIC SURGERY. THE SAMPLE INVOLVED IN THE PATIENT EVENT IS NOT AVAILABLE. HOWEVER, AFTER THE PATIENT EVENT OCCURRED, THE CUSTOMER TESTED 5 SAMPLES WITH SALINE FROM HER STOCK AND IN THREE OF THE SAMPLES, AT LEAST ONE OF THE PORTS WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT WITH THE 5 SAMPLES THE CUSTOMER TESTED. THE CUSTOMER INDICATED THAT ONLY ONE OF THE 3 SAMPLES THAT SHE FOUND TO BE DEFECTIVE IS AVAILABLE FOR EVALUATION. HOWEVER, SHE DOES HAVE A BOX FULL OF UNOPENED PRODUCT FROM THE SAME LOT NUMBER. THE CUSTOMER INDICATED THAT SHE DOES NOT NEED TO RECEIVE THE EVALUATION RESULTS. SHE INDICATED SHE JUST WANTED TO MAKE BAXTER AWARE OF THIS. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2010 AT 1215: PIV INFILTRATED TO L. WRIST. ON RESTART, 24GX5/8" JELCO CATHETER (NEEDLE REMOVED) WAS NOT IN PLACE TO R. HAND, SO ATTEMPT WAS MADE TO REMOVE THE CATHETER BY HUB. CATHETER NOT VISIBLE BUT SNAPPED OFF IN HAND WHEN HUB WAS PULLED ON (FELT LIKE IT "CAUGHT" IN HAND BUT THE CATHETER ITSELF WAS NOT STRETCHING OR VISIBLE). APPROX 1/8" STILL ATTACHED TO HUB AND 4/8" IN HAND. PRESSURE DRESSING APPLIED. PT TRANSPORTED TO (B)(6) FOR SURGICAL REMOVAL OF FOREIGN BODY IN RIGHT HAND.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS CHRONIC IMPLANTABLE TRANSVENOUS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS SUGICALLY CAPPED AFTER AN XRAY IDENTIFIED A CONDUCTOR FRACTURE. HOWEVER, ALL LEAD DIAGNOSTIC MEASUREMENTS (PACING THRESHOLD, SENSING AND IMPEDANCE) WERE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10F09089

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention