BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1812741 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02815
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240. THE REPORT WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, ROOT CAUSE OF THE SE 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. THE AT HOME GUIDE INSTRUCTS USERS TO PLACE SOLUTION BAGS ON A FLAT, STABLE SURFACE AND NOT STACKED ON TOP OF EACH OTHER. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THE EMAIL RECEIVED FOR (B)(6) STUDY INDICATED THAT THE PATIENT HAD NEUROLOGICAL EVENT APHASIA AND RIGHT SIDED HEMIPARESIS. THE PATIENTS PHYSICAL DEFICITS RESOLVED ON THEIR OWN WITHIN 48 HOURS. COGNITIVE DEFICITS STILL IMPROVING AT DISCHARGE .THE PATIENT WAS DIAGNOSED WITH A STROKE. THE PATIENT IS A (B)(6) GENTLEMAN WITH A HISTORY OF CORONARY DISEASE AND A HISTORY OF BILATERAL CAROTID STENOSIS WITH CHRONIC RENAL FAILURE. HE HAS UNDERGONE A PRIOR LEFT CAROTID ENDARTERECTOMY IN 1999. THE PATIENT IS ALSO STATUS POST RIGHT CAROTID ANGIOPLASTY AND STENT FROM 2009. HE HAD RECURRENT STENOSIS IN THE LEFT INTERNAL CAROTID ARTERY WHICH PROGRESSED. HE WAS ASYMPTOMATIC FROM THE STENOSIS BUT IT WAS MEASURING GREATER THAN 90%. THE PATIENT PRESENTED TO (B)(6) ON (B)(6) 2010 TO UNDERGO LEFT CAROTID ANGIOPLASTY AND STENT. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED SYMPTOMS OF APHASIA AND MILD RIGHT HEMIPARESIS. HE WAS FOUND TO HAVE WIDE COMPLEX TACHYCARDIA AND HYPOTENSION. UPON LATER REVIEW IT WAS FOUND TO BE IN ATRIAL IN ORIGIN. HE WAS EVALUATED BY CARDIOLOGY AND ELECTROPHYSIOLOGY. HE ALSO UNDERWENT A RENAL CONSULT. ADJUSTMENTS WERE MADE TO MEDICATIONS. HE UNDERWENT A SPEECH ASSESSMENT. ECHOCARDIOGRAM DEMONSTRATED NORMAL EF, DUE TO THE PATIENT'S INITIAL HYPOTENSIVE EPISODE WITH NEUROLOGIC CHANGES, ON THE DAY OF THE PROCEDURE, HE WAS INTUBATED AND SEDATED AFTER HAVING SEIZURE-LIKE ACTIVITY. THERE WAS NO OCCLUSION ON FOLLOW-UP IMAGING, RAISING CONCERN FOR HYPOTENSIVE EVENT WITH A HISTORY OF SEVERE COPD AND DIABETES. THE PATIENT WAS EXTUBATED ON POST-PROCEDURE DAY #1, HE CONTINUED TO PROGRESS. HIS SPEECH IMPROVED. HIS WEAKNESS RESOLVED. THE PATIENT CONTINUED TO BE MONITORED AND WAS TRANSFERRED TO THE POST-NEUROSURGICAL FLOOR WHERE HE CONTINUED TO PROGRESS. HE HAD SOME HYPERTENSIVE EPISODES. ADJUSTMENTS WERE MADE TO HIS MEDICATIONS.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE UNIT DURING DWELL 5 OF 6. THE HP STATED A SUPPLY BAG FELL AND DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CYCLE POWER. THE HP CONFIRMED SHE WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES. THE TSR ADVISED THE HP TO INFORM HER NURSE OF THE ALARM. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THIS EVENT WAS AN ISOLATED INCIDENT AND HAD NOT OCCURRED BEFORE OR SINCE. THE HP STATED THE ALARM AWOKE HER; SHE DID NOT KNOW HOW THE BAG FELL. THE HP STATED NO INFECTION DEVELOPED AND SHE WAS DOING WELL WITH THERAPY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR