BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML

    MDR report key: 3941628 · Received July 17, 2014

    Report

    Report Number
    1226348-2014-11824
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 10, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    LKK
    PMA / PMN Number
    PP890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. COMPLAINT SAMPLE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED: THE COMPLAINT WAS CONFIRMED. IT HAS BEEN SHOWN THAT THE PUMP FAILURE WAS NOT RELATED TO THE PUMP HARDWARE INTEGRITY, BUT MOST PROBABLY TO A POSSIBLE INTERFERENCE WITH THE MRI EXAMINATION ONTO THE PUMP. BACKGROUND CODMAN WAS INFORMED OF A 20ML PUMP HARDWARE FAILURE [11] THAT WAS REPORTED BY (B)(6) AFTER AN MRI SCAN PERFORMED ON (B)(6) 2014. THE PUMP REFILLS ARE USUALLY PERFORMED IN (B)(6). THE LOCAL SALES REPRESENTATIVE WAS DURING THE MRI, ON (B)(6) 2014, TO BE ABLE TO INVESTIGATE THE PUMP IN CASE OF HW11. THE MEDSTREAM PUMP WAS IMPLANTED SINCE (B)(6) 2010, AND THIS WAS THE FIRST REPORTED HW11 SINCE PUMP IMPLANTATION. THE CODMAN WAS INFORMED ON (B)(6) 2014 THAT THE PATIENT SUFFERED OF WITHDRAWAL SYMPTOMS AFTER MEDICATION RESUMPTION. THE PUMP WAS VERIFIED BY THE LOCAL REPRESENTATIVE AND THE COLLECTED DATA PROVIDED WERE REVIEWED AND NO DISCREPANCY WAS OBSERVED. THE PUMP WAS FLOWING WITHIN THE SPECIFICATIONS. THE CATHETER AND THE DRUG CONCENTRATION WILL BE VERIFIED BY THE SURGEON. THIS ISSUE IS NOT RELATED WITH THE PREVIOUS HARDWARE FAILURE 11 REPORTED. ONSITE TECHNICAL SUPPORT. THE PUMP NKBG09 WAS FLOWING NORMALLY (NO ALARM) BEFORE THE MRI EXAMINATION, ON (B)(6) 2014. ACCORDING TO THE SALES REPRESENTATIVE, THE PUMP INTERROGATION PERFORMED AFTER THE MRI WAS REPORTING AN ¿HARDWARE FAILURE [11]¿. THIS COULD BE VERIFIED BY THE TRANSACTION LOG CORRESPONDING TO THE PUMP INTERROGATION AFTER THE MRI THAT WAS REPORTING A PUMP HARDWARE ERROR 11 AND A PUMP RESET EVENT, WHICH CORRESPONDS TO THE KNOWN MRI INTERFERENCE SYMPTOMS. THE SALES REPRESENTATIVE USED HIS TECHNICAL KEY BY MISTAKE TO CLEAR THE ERRORS FLAGS, BEFORE HE COULD GATHER ANY PUMP INFORMATION SUCH AS THE PUMP STATUS, ERROR AND SENSOR. IT WAS THEREFORE NOT POSSIBLE TO ANALYZE THE PUMP STATUS IMMEDIATELY AFTER THE MRI, NOR CHECK IF THE PUMP ALARM WAS BEEPING. THE PUMP INTERROGATION PERFORMED DURING FIELD VISIT BY MEANS OF A HARDWARE TECHNICIAN KEY GAVE THE FOLLOWING VALUES: READ STATUS: 60, 02, 14, 21, DB, 0F, 40, 38, D2. READ ERRORS: 00, 00, 00, 00. READ SENSORS: 70, 55, 04, 00, CF, 35, 54, 0B, 63, 88, 06, 08, BA, 00, A0, 0F, 36, 02, 0C, 04. THE VALUES ABOVE ARE CONSISTENT WITH THE EXPECTED STATUS AND SENSOR MEASUREMENTS. THE CORRESPONDING TEMPERATURE MEASUREMENT IS 35.375°C, AND THE FLS FREQUENCY MEASUREMENT IS 284016 HZ WHICH CORRESPONDS TO 10.36 ML. NO ERROR WAS REPORTED AS THE ERROR FLAGS WERE PREVIOUSLY CLEARED BY THE SALES REPRESENTATIVE. BASED ONTO THE INFORMATION PROVIDED, THE BOARD CONCLUDED THAT THE AFTER A FORCED SELF-TEST AND CONSISTENT PUMP INTERROGATION, THE PHYSICIAN COULD RESUME THE MEDICATION (THE ERRORS FLAGS WERE PREVIOUSLY CLEARED BY THE SALES REPRESENTATIVE). A DHR REVIEW WAS PERFORMED FOR THE MEDSTREAM PUMP 91-4200 S/N: (B)(4) (LOT#CLBBY7), AND THE LOT MET SPECIFICATIONS WHEN RELEASED ON (B)(4) 2010. THE PUMP WAS VERIFIED THE SAME DAY BY THE LOCAL REPRESENTATIVE THE COLLECTED DATA WERE DISCUSSED DURING A BOARD MEETING ON (B)(4) 2014. CORRECTIVE ACTION ((B)(4)) WAS IMPLEMENTED TO AVOID THIS DEFECT, EFFECTIVENESS HAS BEEN DEMONSTRATED FOR PUMPS MANUFACTURED AFTER CAPA IMPLEMENTATION ((B)(4)2010). THE PUMP INVOLVED IN THIS COMPLAINT WAS MANUFACTURED PRIOR THE IMPLEMENTATION OF THE CAPA. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A LOCAL SALES REP A HW11 ERROR OCCURED AFTER MRI. RESET THE PUMP AND RESTART IT. THE PUMP REMAIN IMPLANTED. (B)(6) 2014 YES, THE PUMP WAS MANUFACTURED WITH THE OLD IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419147 MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF CLBBY7

    Patients

    Seq Age Sex Outcome Treatment
    1