BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 3000 - 30ML VOLUME, HIG

    MDR report key: 7366908 · Received March 23, 2018

    Report

    Report Number
    1226348-2018-00538
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    February 22, 2018
    Report Date
    February 23, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    LKK
    UDI-DI
    10886704043591
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #1226348-2018-00538. ADDITIONAL INFORMATION RECEIVED ON APRIL 11, 2018: DEVICE WAS RECEIVED FOR EVALUATION ON APRIL 11, 2018.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #1226348-2018-00538. CONCLUSION: A CODMAN 3000 PUMP, SERIAL NUMBER (B)(4), WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION SHOWED NO ANOMALIES ON THE EXTERIOR METAL SURFACE OF THE PUMP. THE SEPTUM FELT NORMAL WITH PUNCTURE MARKS CONSISTENT WITH NEEDLE PENETRATION. 18.75¿ OF WHITE CATHETER WAS ATTACHED TO THE PUMP AND NOT CLAMPED OR TIED AT THE DISTAL END. APPROXIMATELY .483ML OF CLEAR LIQUID AND APPROXIMATELY 4ML OF AIR WAS EMPTIED FROM THE RESERVOIR. THE BOLUS PATHWAY AND CATHETER WERE FLUSHED WITH NO RESISTANCE. THE FLOW PATH AND CATHETER WERE ANOMALY FREE. A CLEAR LIQUID WAS COLLECTED. NO LEAKS WERE NOTED FROM THE SEPTUM OR CATHETER WHEN FLUSHING AND PRESSURIZING. THE RESERVOIR WAS FILLED WITH 30MLS OF BACTERIOSTATIC WATER AND PLACED IN A 37 DEGREE CELSIUS WATER BATH FOR FLOW TESTING. THE PUMP FLOWED AN AVERAGE OF 1.9054 ML/DAY , 105.8% OF MANUFACTURED FLOW RATE OF 1.8 MLS/DAY. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THIS PUMP MET ALL TESTING REQUIREMENTS AND FUNCTIONED PER SPECIFICATION DURING THE MANUFACTURING PROCESS. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INITIAL MDR IS THE ONLY REPORT BEING SUBMITTED FOR MFR REPORT #1226348-2018-00538. ADDITIONAL PATIENT INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE. INITIAL REPORTER INFORMATION HAS BEEN REQUESTED, HOWEVER IS UNKNOWN AT THIS TIME. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A CODMAN 3000 DRUG PUMP (AP03000H/15843) DID NOT FLOW AFTER IT WAS PRIMED FOR SURGERY ON (B)(6) 2018. THERE WERE NO DROPS SEEN COMING FROM THE CATHETER. HEPARINIZED SALINE HAD BEEN IN THE PUMP, BUT IT WAS EMPTIED. A SECOND PUMP WAS IMPLANTED IN THE PATIENT TO COMPLETE THE PROCEDURE. THERE WAS A 20 MINUTE PROCEDURAL DELAY IN ORDER TO PREPARE THE SECOND PUMP. THE PATIENT WAS A (B)(6) YEAR-OLD FEMALE WITH A HISTORY OF BREAST CANCER WITH METASTASIS TO THE LIVER. IT WAS NOTED THAT THE PUMP HAD BEEN DROPPED ON THE FLOOR PRIOR TO THE PROCEDURE, HOWEVER, NO DAMAGE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208804 MODEL 3000 - 30ML VOLUME, HIG PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN AND SHURTLEFF, INC 15843 10886704043591

    Patients

    Seq Age Sex Outcome Treatment
    1