BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1820787 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03016
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED AND A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO THE PATIENT USING A SHARP OBJECT TO OPEN THE PACKAGING OF A SOLUTION BAG. A LABELING REVIEW FOUND THE HOMECHOICE USER'S MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR 2240 ALARM (INDICATING AIR IN THE SET) ON THE HOMECHOICE (HC) MACHINE DURING PATIENT USE. THE HOME PATIENT (HP) HAD TWO BAGS CONNECTED AND THERE WAS A LEAK AROUND THE SUPPLY BAG. THE HP COULD NOT SEE WHERE THE LEAK WAS COMING FROM, BUT SAW FLUID UNDER THE BAG. THE HP HAD USED A COMPACT EXCHANGE DEVICE AND DOES CUT THE PACKAGING OF THE BAGS OPEN. THE HP WAS REFERRED TO THE REGISTERED NURSE (RN) ABOUT THE LEAK AND THE MISSED THERAPY. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. UPON FOLLOW-UP WITH THE PERITONEAL DIALYSIS RN ON (B)(6) 2010, IT WAS FOUND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION RELATED TO THE EVENT.

    Description of Event or Problem · 1

    THE PT WAS AN INPATIENT AT (B)(6), WITH A COMPLICATED MEDICAL HISTORY INCLUDING PRIMARY PULMONARY HYPERTENSION ("PPH"). THE PT'S STATUS WAS "DO NOT RESUSCITATE/DO NOT INTUBATE" (DNR/DNI). FOR THE PPH, THE PT RECEIVED FLOLAN WHICH WAS ADMINISTERED THROUGH A CADD-LEGACY INFUSION PUMP. THE PUMP WAS CHECKED, AS A MATTER OF ROUTINE, BY NURSING STAFF AT 11:00 PM, ON (B)(6) 2010, AND FOUND THAT THE PUMP WAS WORKING APPROPRIATELY AND THAT 59.6 ML OF MEDICATION REMAINED IN THE CASSETTE. DURING THE NIGHT OF (B)(6) 2010, THE PT REQUIRED NURSING ATTENTION FOR VARIOUS ISSUES, INCLUDING BEING COLD, NAUSEA AND AGITATION. AS A RESULT, NURSING STAFF ENTERED THE ROOM AND INTERACTED WITH THIS PT SEVERAL TIMES DURING THE NIGHT. IN THE EARLY MORNING HOURS OF (B)(6) 2010, THE PT WAS AGITATED AND REFUSED NURSING ATTENTION, REQUESTING INSTEAD THAT HE BE ASSISTED TO THE BATHROOM, AND THIS WAS DONE. AT 6:00 AM, LESS THAN AN HOUR AND A HALF USING THE RESTROOM, WHILE THE PT WAS BEING CARED FOR BY STAFF, HE SUDDENLY BECAME UNRESPONSIVE. AFTER INITIALLY CALLING A "CODE BLUE", MEDICAL STAFF REALIZED THAT THE PT HAD "DNR" STATUS; RESUSCITATION EFFORTS WERE ABORTED; AND THE PT WAS PRONOUNCED DEAD AT 6:15 AM. IN THE COURSE OF POST-MORTEM CARE, A NURSE NOTED THAT THE SCREEN OF THE CADD-LEGACY PUMP USED FOR THE FLOLAN INFUSION INDICATED THAT THE DEVICE WAS IN "STOPPED" MODE. SUBSEQUENT EXAMINATION REVEALED THE REMAINING CASSETTE VOLUME IN THE PUMP TO BE APPROX 59 ML, ONLY 0.6 ML LESS THAN THE VOLUME AT 11:00 PM ON THE PREVIOUS NIGHT. ACCORDING TO THE SETTINGS ON THE PUMP, CONSIDERABLY MORE THAN 0.6 ML SHOULD HAVE BEEN DELIVERED TO THE PT IF THE PUMP HAD BEEN INFUSING IN ACCORDANCE WITH THE SETTINGS DURING THE NIGHT. SUBSEQUENT INVESTIGATION HAS NOT REVEALED THAT ANY HOSPITAL STAFF MEMBER OPERATED THE CONTROLS ON THE INFUSION PUMP TO PUT IT INTO "STOPPED" MODE ON THE NIGHT IN QUESTION. THIS SUGGEST THAT THE DEVICE MALFUNCTIONED IS SOME WAY SUCH THAT THE INFUSION PUMP SPONTANEOUSLY OR THROUGH SOME OUTSIDE INFLUENCE OTHER THAN AN INTENTIONAL ACT BY A MEDICAL STAFF MEMBER, WENT INTO "STOPPED" MODE AND STOPPED INFUSING FLOLAN TO THE PT. IN ADDITION, ALTHOUGH THE INFUSION PUMP IS EQUIPPED WITH AN AUDIBLE ALARM WHICH SHOULD HAVE SOUNDED WHEN THE DEVICE ENTERED THE "STOPPED" MODE, NO SUCH ALARM WAS DETECTED BY NURSING STAFF DESPITE FREQUENT VISITS TO THE PT'S ROOM DURING THE RELEVANT TIME PERIOD. LIKEWISE, THE PT HIMSELF (WHO USED THE CADD LEGACY PUMP AT HOME PRIOR TO HIS ADMISSION AND WAS EXPERIENCED IN THE USE OF THE CADD LEGACY PUMP) DID NOT REPORT HEARING ANY ALARM DURING THE NIGHT OF (B)(6) 2010. THUS, THE HOSPITAL IS CONCERNED THAT THE ALARM FOR THE CADD LEGACY INFUSION PUMP MAY HAVE MALFUNCTIONED AND FAILED TO SOUND AT ALL WHEN THE PUMP WENT INTO "STOPPED" MODE ON THE NIGHT IN QUESTION. ALTERNATIVELY, IF THE ALARM DID GO OFF WHEN THE PUMP ENTERED "STOPPED" MODE (AND IT IS THE HOSPITAL'S UNDERSTANDING THAT THE ALARM SHOULD HAVE SOUNDED EVERY FIVE MINUTES UNTIL A MEDICAL STAFF MEMBER CHECKED THE PUMP), IT APPARENTLY WAS NOT SUFFICIENTLY CONSPICUOUS OR AUDIBLE TO ATTRACT THE ATTENTION OF MEDICAL PERSONNEL WHO WERE IN THE ROOM AND ATTENDING TO THE PT DURING THAT TIME. AS SUCH, THE AUDIBLE ALARM FAILED TO ALERT MEDICAL STAFF TO THE POSSIBILITY OF A MALFUNCTION OR A CHANGE IN STATUS. ADDITIONALLY, THE DEVICE IS DESIGNED TO BE WRAPPED IN COLD GEL PACKS (FOR THE INTEGRITY OF THE MEDICATION) AND KEPT IN WATERPROOF POUCH. THUS, THE QUESTION ARISES AS TO WHETHER THE AUDIBLE ALARMS ARE LOUD ENOUGH TO BE DETECTED WHEN THE DEVICE IS USED AS RECOMMENDED. THE HOSPITAL INITIATED AN INVESTIGATION AND THE INFUSION PUMP HAS BEEN SEQUESTERED. THE "EVENTS" LOGGED WITHIN THE MEMORY OF THE INFUSION PUMP HAVE NOT, AT THIS POINT, BEEN RETRIEVED. THIS INFO MAY BE HELPFUL IN DETERMINING WHETHER THE PUMP WAS STOPPED BY THE PT, A MEDICAL STAFF MEMBER OR SOME OTHER PERSON, INTENTIONALLY OR INADVERTENTLY, DURING THE NIGHT; WHETHER IT ENTERED "STOPPED" MODE DUE TO A MALFUNCTION; OR WHETHER IT ENTERED THE "STOPPED" MODE FOR SOME OTHER AS YET UNK REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR