BEUDAMED
    FDA Adverse Event Summary report: N

    PAIN CARE 3000

    MDR report key: 399832 · Received June 14, 2002

    Report

    Report Number
    MW4003305
    Date Received
    June 14, 2002
    Date of Event
    February 1, 2002
    Report Date
    May 23, 2002
    Manufacturer
    BREGG INC
    Product Code
    MEB
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOUR POST OP KNEE SURGERY PTS USING THE BREGG PAIN CARE 3000 WERE NOTED TO HAVE WOUND NECROSIS. ALL PTS WITH THIS SCENARIO HAD THE SAME ORTHOPEDIC SURGEON. THE MEDICATION DELIVERED BY THE PAIN PUMP WAS MARCAINE 0.5% WITH EPINEPHRINE. THE COMPLICATIONS WERE NOTED AND INFO REGARDING THESE INCIDENTS WAS BROUGHT TOGETHER ON 3/02.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/23/02: THE DEVICE FAILURE MENTIONED IN THE REPORT WAS THE RESULT OF A FAILED GLUE JOINT ATTACHING THE MANIFOLD TO THE BODY. THERE ARE TWO LOCATIONS OF THE JOINT WHICH MFR HAS NOTED ON THE ATTACHED DRAWING WITH AN 'X'. THE FAILURE OF THIS JOINT ALLOWED THE MEDICATION IN THE UNIT TO LEAK OUT THE PORT LABELED AS #1. THE UNITS ARE 100% PRESSURE TESTED PRIOR TO SHIPPING. MFG WAS STOPPED. CAPA SHOWED THAT THE ASSEMBLY OF THE MANIFOLD TO THE FILTER WAS A TIGHT FIT WHICH PLACED STRESS ON THE ASSEMBLED JOINT. OVER TIME AND THE PRESSURE OF FILLING THE UNIT WITH 200CC OF MEDICATION, SOME OF THE JOINTS WERE CRACKING AND ALLOWING LEAKS. THE REPORT AS WRITTEN DOES NOT DEMONSTRATE A CLEAR UNDERSTANDING OF THE PROBLEM WHICH WAS MECHANICAL IN NATURE. CORRECTION INVOLVED DIMENSIONAL CHANGES TO THE MANIFOLD PART TO GET A BETTER FIT, REMOVING THE STRESS ON THE ASSEMBLY. THE CHANGE WAS VALIDATED AND MFG RESUMED. THE PROBLEM WAS LIMITED TO A SPECIFIC GROUP OF MANIFOLD PARTS, WHICH ALLOWED THOSE UNITS INVOLVED TO BE IDENTIFIED AND REMOVED FROM THE FIELD. THIS REMOVAL IS DOCUMENTED IN THE CAPA. UNDER SECTION 519(F) OF THE ACT REPORTING A REMOVAL TO THE FDA IS REQUIRED ONLY TO 1) REDUCE A RISK TO HEALTH POSED BY THE DEVICE AND 2) TO REMEDY A VIOLATION OF THE ACT CAUSED BY A DEVICE WHICH MAY PRESENT A HEALTH RISK. IN THIS INSTANCE NEITHER OF THESE WAS TRUE. ASKED ABOUT THE CHANGE IN THE PISTON BOOT SEAL. THIS CHANGE WAS A DESIGN IMPROVEMENT TO AN INTERNAL LEAK OF THE PRODUCT AND WAS NOT EVIDENT TO THE PT. AT NO TIME WAS THE SAFETY OR EFFICACY OF THE PART INVOLVED. SINCE THERE WAS NO CHANGE TO THE SAFETY OR EFFICACY, THIS IMPROVEMENT WAS HANDLED THROUGH DESIGN CONTROL AND THE CHANGE IMPLEMENTED AT THE SAME TIME THAT THE PROCESS WAS STOPPED TO FIX THE MANIFOLD PROBLEM. NO 510(K) IS REQUIRED. THE RESPONSE TO THE LETTER DATED 8/19/02 IS NUMBERED TO CORRESPOND TO THOSE QUESTIONS WHICH ARE ASKED. 1. THE DESCRIPTION OF THE EVENT IN THE REPORT NOTES FOUR POST-OP KNEE SURGERY PTS USING THE BREG PAIN CARE 3000 WERE NOTED TO HAVE WOUND NECROSIS. REPORTS TO BREG INDICATE 'BLISTER FORMATIONS' IN ALL REPORTS, BUT THE USE OF THE TERM NECROSIS VARIES DEPENDENT UPON WHO IS REPORTING. 2. BREG, INC IS NOT AWARE OF ANY EVALUATION OF THE INCIDENT BY THE INDIVIDUALS NOTED IN THIS QUESTION. 3. IN A PHONE CALL DATED 3/13/02, DR SPOKE TO BREG REGARDING WHAT THEY DESCRIBED AS 'FRACTURE BLISTERS' IN SOME OF THEIR ACL SURGERY PTS. DR PRESCRIBED THE MEDICATION USED (EPINEPHRINE, A KNOWN VASOCONSTRICTOR), THE PLACEMENT OF THE CATHETER AND THE ACKNOWLEDGED OFF BRAND USE OF PART OF THE PAIN CARE 3000 KIT WITH ANOTHER INFUSION SYSTEM. BREG CONCLUDED THAT THIS OCCURRENCE WAS NOT ATTRIBUTABLE TO THE PAIN CARE 3000. ON 4/25/02, BREG WAS CONTACTED BY HOSP RISK MGMT ADVISING BREG OF RECENT EVENTS IN SURGERY POSSIBLE RELATING TO THE PAIN CARE 3000. THIS CALL WAS RETURNED BY BREG WHO QUESTIONED THEM AND OTHERS REGARDING THESE INCIDENTS. BASED UPON THESE CONVERSATIONS IT WAS DETERMINED THAT THESE EVENTS WERE IN FACT THE SAME AS THOSE REPORTED BY DR IN MARCH. ONCE AGAIN, BASED UPON THIS INFO, BREG REACHED THE SAME CONCLUSION REGARDING THE PAIN CARE 3000. A SUMMARY OF THESE CONVERSATIONS IS ATTACHED. ON 8/21 DURING THE DISCUSSION REGARDING A REPORTED LEAK WITH THE PAIN CARE 3000, FDA ANALYST MENTIONED THIS VOLUNTARY REPORT. UPON INVESTIGATION, IT IS NOTED THAT IT WAS FILED ON 5/23/02 BY THE HOSP. 4. DEVICE LABELING FOR CLINICAL AND PTS IS ATTACHED. DEVICES ARE NOT AVAILABLE. 6. A) PAIN CARE 3000 IS INTENDED TO PROVIDE CONTINUOUS INFUSION OF A LOCAL ANESTHETIC INTO AN INTRA-OPERATIVE SITE FOR THE POST-OP MGMT OF PAIN. B) BREG DID NOT OBTAIN CULTURES, BUT DR INDICATED THAT IN ONE CASE, THE RESULTS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN CARE 3000 PAIN PUMP MEB BREGG INC 3000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO