BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 2M8063,

    MDR report key: 1710453 · Received June 4, 2010

    Report

    Report Number
    6000001-2010-00631
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 14, 2010
    Report Date
    May 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH A LOW BATTERY ALARM WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY THE MAIN BATTERY NOT BEING ABLE TO BE CHARGED WHICH, IN TURN, WAS CAUSED BY A CRACKED POWER SUPPLY PRINTED CIRCUIT BOARD. THIS IS A BAXTER OWNED DEVICE AND NO REPAIRS WILL BE MADE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WITH A LOW BATTERY ALARM WHICH INTERRUPTED A PATIENT INFUSION IN THE FACILITY'S LONG TERM CARE AREA. THE PUMP WAS SWAPPED OUT AND THE INFUSION RESUMED ON ANOTHER DEVICE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE STENT WAS SUCCESSFULLY PLACED ACROSS THE STENOTIC LESION IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT. THERE WERE NO POST PROCEDURAL COMPLICATIONS AND THE FOLLOWING DAY THE PATIENT WAS DISCHARGED HOME WITHOUT ANY NEUROLOGICAL DEFICITS. FOUR DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH A SEVERE HEADACHE. IMAGING REVEALED A MILD LEFT TEMPORAL SUBARACHNOID HEMORRHAGE (SAH) EXTENDING ALONG THE SYLVIAN FISSURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. TWO DAYS LATER THE IMAGING SHOWED THE SAH HAD DECREASED AND THE STENT APPEARED TO BE PATENT. THE PATIENT WAS DISCHARGED HOME. HOWEVER, THE NEXT DAY THE PATIENT WAS READMITTED WITH CONTINUED COMPLAINT OF HEADACHE. IMAGING DEMONSTRATED "EXPECTED EVOLUTION OF A SMALL AMOUNT OF SAH IN THE LEFT SYLVIAN FISSURE" WITH NO NEW ACUTE CHANGES. THE PATIENT WAS GIVEN BENADRYL AND COMPAZINE (DOSE UNKNOWN) ALONG WITH MAGNESIUM AND DEPACON FOR HEADACHE PREVENTION. THE PATIENT'S CONDITION IMPROVED AND TWO DAYS LATER SHE WAS DISCHARGED HOME IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 2M8063, PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1