BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1841716 · Received September 22, 2010

    Report

    Report Number
    1423500-2010-03623
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 29, 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 LOW DRAIN VOLUME ALARM. THE REPORT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS NOT DETERMINED. 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). PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER (CG) WHO STATED THE HOME PATIENT (HP) WAS ABLE TO RESUME WITH THERAPY BY STARTING WITH NEW SUPPLIES. NO DEFECTS WERE NOTED AT THE TIME AND THERE WERE NO SAMPLES OR LOT NUMBER TO PROVIDE.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY AND LOT INFORMATION ARE UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A LOW DRAIN VOLUME ALARM ON THE HOMECHOICE (HC) UNIT DURING DRAIN 1 OF 1. THE DRAIN VOLUME (DV) = 474 ML WHEN THE ALARM OCCURRED AND THE LAST VOLUME INFUSED = 1400 ML. THE HP STATED SHE HAD BEEN TRYING TO DRAIN FOR A LONG TIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CLOSE AND OPEN THE TRANSFER SET AND TO CHECK THE PATIENT LINE. THE HP STATED SHE FOUND AIR IN THE PATIENT LINE. THE TSR ADVISED THE HP TO CYCLE POWER AND ASSISTED THE HP TO END THERAPY. THE TSR INSTRUCTED THE HP TO TRY TO DRAIN OUT WITH AN ULTRA BAG. THE TSR ADVISED THE HP IF SHE WAS UNABLE TO DRAIN OUT WITH THE ULTRA BAG, TO CONTACT HER NURSE ABOUT DIFFICULTY DRAINING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE A GUIDE WIRE DETACHMENT OCCURRED. ANTEGRADE ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY. THE TOTALLY OCCLUDED, APPROXIMATELY 10CM IN LENGTH, TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED PROXIMAL FIBULAR ARTERY. A 5F NON-BSC SHEATH AND UNSPECIFIED SIZED NON-BSC CATHETER WERE PLACED. A PT2 LIGHT SUPPORT 300CM STRAIGHT GUIDE WIRE WAS ADVANCED; HOWEVER, AT THE VERY HEAVILY CALCIFIED PORTION OF THE LESION, THE PHYSICIAN WAS TWISTING AND "FORCING" THE WIRE AND NOTICED THAT 1-1.5CM OF THE WIRE TORE OFF. THE DETACHED PORTION WAS LODGED IN THE SUBINTIMAL AND DID NOT MOVE. A NEW PT2 GUIDE WIRE WAS ADVANCED AND ABLE TO CROSS THE LESION. THE CATHETER WAS EXCHANGED FOR AN UNSPECIFIED HYDROPHILIC CATHETER. A 2MMX8CM NON-BSC BALLOON WAS USED TO DILATE THE LESION TO A FINAL DIAMETER OF 2.5MM. THE DETACHED PORTION OF THE WIRE REMAINS IN THE PATIENT. IT IS THE PHYSICIAN'S OPINION THAT SINCE THE WIRE FRAGMENT IS IN THE SUBINTIMAL, NO FURTHER ACTION IS NEEDED. A DUPLEX STUDY WILL BE PERFORMED IN 4-6 WEEKS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION WAS RECEIVED.

    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 82 YR