BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1832350 · Received September 13, 2010

    Report

    Report Number
    1423500-2010-03363
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN, AND PATIENT DISCARDS SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR THE SUSPECT LOT NUMBER (H10D27011), WITH NO DEFECTS NOTED. THE ROOT CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF BACTERIAL PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS TREATMENT. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON (B)(6)2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. IN (B)(6)2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH WAS POSITIVE FOR KLEBSIELLA PNEUMONIAE. THE NURSE WAS "NOT SURE WHERE CONTAMINATION BEGAN." TREATMENT INFORMATION WAS NOT PROVIDED. PD THERAPY WAS ONGOING AT THE TIME OF THE EVENT. ON AN UNREPORTED DATE IN 2010, THE PATIENT RECOVERED FROM THE EVENT. ON (B)(6)2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN 2010, THE PATIENT RECOVERED FROM THE EVENT. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR KLEBSIELLA PNEUMONIAE WAS NOT RELATED TO PD THERAPY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, CDE CALLING ON PT'S BEHALF TO REPORT RECENT ELEVATED BLOOD GLUCOSE. NURSE STATED PT'S ELEVATED BLOOD GLUCOSE WAS THE RESULT OF PT ERROR, NOT DUE TO THE INFUSION DEVICE. ON CALL BACK, CDE REPORTED SHE WAS CALLED TO ASSIST PT WHO WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 FOR HYPERGLYCEMIA. CDE STATED PT'S PAPERWORK INDICATED HE WAS RECEIVING 'HI' ON HIS BLOOD GLUCOSE METER AND CALLED 911. CDE REPORTED THE EMTS ALSO RECEIVED 'HI' ON THEIR METER AND THE BLOOD WORK IN THE ER INDICATED THE PT'S BLOOD GLUCOSE WAS 700 MG/DL. CDE STATED THE PT INFORMED HER THIS EVENING THAT ON (B)(6) 2010 "HE DISCOVERED HE DID NOT HAVE A GOOD SITE." CDE REPORTED PT STATED HE WAS NOT AT HOME AND DID NOT HAVE EXTRA SUPPLIES WITH HIM TO CHANGE HIS INFUSION SITE. CDE STATED PT TOLD HER HIS INFUSION SITE HAD BEEN DISCONNECTED/DISLODGED WHEN HE WAS SLEEPING. REVIEWED INFUSION DEVICE ERROR HISTORY. CDE STATED PT MAY NOT HAVE BEEN AWARE OF DISCONNECTED/DISLODGED INFUSION SITE UNTIL METER READ 'HI'. CDE REPORTED SHE DID NOT THINK THERE WAS A LEAK IN THE SYSTEM. THE INFUSION DEVICE CLOCK WAS NOT CORRECT AS PT HAD NOT CHANGED IT FOR DAYLIGHT SAVINGS TIME; CDE TO CORRECT. CDE STATED PT'S BASAL RATES WERE SEVERAL 10THS OFF WHAT HAD BEEN ADVISED; CDE CORRECTED THESE THIS EVENING. CDE REPORTED PT DOES NOT KNOW HOW TO CALCULATE HIS BOLUS AMOUNTS BASED ON CARB COUNTING; INSTEAD, THEY HAVE IT BASED ON 1.0 UNIT OF INSULIN PER "FOOD ITEM." CDE STATED SHE FEELS INFUSION DEVICE IS FUNCTIONING PROPERLY AND PT NEEDS MONITORING AND RE-TRAINING. CDE REPORTED SHE WILL ASSIST PT IN SETTING HIS BACKUP INFUSION DEVICE AND BACK ON PUMP THERAPY PRIOR TO BEING RELEASED FROM HOSPITAL. SUBMITTED REQUEST FOR ASSISTANCE FROM TRAINER. ON (B)(6) 2010, COMPANY REP REPORTED BEING IN CONVERSATION WITH CLINICAL SPECIALIST AND THEY WILL FOLLOW UP WITH PT'S TRAINING ON (B)(6) 2010. COMPANY REP REPORTED PT WAS RELEASED ON (B)(6) 2010 AND HAS HAD NO CONCERNS WITH INFUSION SITES OR OCCLUSIONS SINCE BEING HOME AND GLUCOSE IS DECREASING. PT'S NORMAL BLOOD GLUCOSE RANGE IS NOT KNOWN. COMPANY REP STATED PT WAS IN CLASS AND HIS METER READING WAS 'HI' SEVERAL TIMES AND HIS INSTRUCTOR CALLED 911. COMPANY REP REPORTED PT STATED HE WAS TREATED WITH INSULIN IV AND INSULIN INJECTIONS; THOUGH HIS BLOOD GLUCOSE WAS 174 MG/DL WHEN RELEASED FROM THE HOSPITAL. NO PRODUCT RETURN WAS REQUESTED.

    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 44 YR Hospitalization| R DIANEAL PD4 AMBUFLEX