BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTA-MIX 2400

    MDR report key: 1613679 · Received February 10, 2010

    Report

    Report Number
    1419106-2010-00004
    Event Type
    Other
    Date Received
    February 10, 2010
    Date of Event
    January 13, 2010
    Report Date
    February 4, 2010
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: YES. UNIT WAS RETURNED AND EVALUATED BY BAXA. INSULIN, DEXTROSE AND NEO-TRACE4 ALL DELIVERED AS REQUESTED WITHOUT ERROR. COMPOUNDER WAS FOUND TO FUNCTION AS INTENDED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, (B)(6) HOSPITAL STAFF CALLED BAXA TECHNICAL SUPPORT TO REPORT THAT 4 PATIENTS, WHO HAD RECEIVED TPN ON (B)(6) 2010, EXPERIENCED HYPOGLYCEMIA. THE PHARMACY BELIEVED THIS WAS DUE TO A LESS THAN ANTICIPATED AMOUNT OF DEXTROSE IN THE SUBJECT TPN BAGS. THE TPNS WERE STOPPED AND ADDITIONAL DEXTROSE WAS DELIVERED TO THE PATIENTS. UPON FURTHER COMMUNICATION WITH THE CUSTOMER, THE NUMBER OF PATIENTS INVOLVED WAS INCREASED TO 5. ALL PATIENTS ARE IN STABLE CONDITION.

    Additional Manufacturer Narrative · 2

    DEVICE EVALUATED BY MANUFACTURER: YES. UNIT WAS RETURNED AND EVALUATED BY BAXA. INSULIN, DEXTROSE AND NEO-TRACE4 ALL DELIVERED AS REQUESTED WITHOUT ERROR. COMPOUNDER WAS FOUND TO FUNCTION AS INTENDED.

    Description of Event or Problem · 2

    ON (B)(6) 2010, (B)(6) HOSPITAL STAFF CALLED BAXA TECHNICAL SUPPORT TO REPORT THAT 4 PATIENTS, WHO HAD RECEIVED TPN ON (B)(6) 2010, EXPERIENCED HYPOGLYCEMIA. THE PHARMACY BELIEVED THIS WAS DUE TO A LESS THAN ANTICIPATED AMOUNT OF DEXTROSE IN THE SUBJECT TPN BAGS. THE TPNS WERE STOPPED AND ADDITIONAL DEXTROSE WAS DELIVERED TO THE PATIENTS. UPON FURTHER COMMUNICATION WITH THE CUSTOMER, THE NUMBER OF PATIENTS INVOLVED WAS INCREASED TO 5. ALL PATIENTS ARE IN STABLE CONDITION.

    Additional Manufacturer Narrative · 3

    DEVICE EVALUATED BY MANUFACTURER: YES. UNIT WAS RETURNED AND EVALUATED BY BAXA. INSULIN, DEXTROSE AND NEO-TRACE4 ALL DELIVERED AS REQUESTED WITHOUT ERROR. COMPOUNDER WAS FOUND TO FUNCTION AS INTENDED.

    Description of Event or Problem · 3

    ON (B)(6) 2010, (B)(6) HOSPITAL STAFF CALLED BAXA TECHNICAL SUPPORT TO REPORT THAT 4 PATIENTS, WHO HAD RECEIVED TPN ON (B)(6) 2010, EXPERIENCED HYPOGLYCEMIA. THE PHARMACY BELIEVED THIS WAS DUE TO A LESS THAN ANTICIPATED AMOUNT OF DEXTROSE IN THE SUBJECT TPN BAGS. THE TPNS WERE STOPPED AND ADDITIONAL DEXTROSE WAS DELIVERED TO THE PATIENTS. UPON FURTHER COMMUNICATION WITH THE CUSTOMER, THE NUMBER OF PATIENTS INVOLVED WAS INCREASED TO 5. ALL PATIENTS ARE IN STABLE CONDITION.

    Additional Manufacturer Narrative · 4

    DEVICE EVALUATED BY MANUFACTURER: YES. UNIT WAS RETURNED AND EVALUATED BY BAXA. INSULIN, DEXTROSE AND NEO-TRACE4 ALL DELIVERED AS REQUESTED WITHOUT ERROR. COMPOUNDER WAS FOUND TO FUNCTION AS INTENDED.

    Description of Event or Problem · 4

    ON (B)(6) 2010, (B)(6) HOSPITAL STAFF CALLED BAXA TECHNICAL SUPPORT TO REPORT THAT 4 PATIENTS, WHO HAD RECEIVED TPN ON (B)(6) 2010, EXPERIENCED HYPOGLYCEMIA. THE PHARMACY BELIEVED THIS WAS DUE TO A LESS THAN ANTICIPATED AMOUNT OF DEXTROSE IN THE SUBJECT TPN BAGS. THE TPNS WERE STOPPED AND ADDITIONAL DEXTROSE WAS DELIVERED TO THE PATIENTS. UPON FURTHER COMMUNICATION WITH THE CUSTOMER, THE NUMBER OF PATIENTS INVOLVED WAS INCREASED TO 5. ALL PATIENTS ARE IN STABLE CONDITION.

    Additional Manufacturer Narrative · 5

    DEVICE EVALUATED BY MANUFACTURER: YES. UNIT WAS RETURNED AND EVALUATED BY BAXA. INSULIN, DEXTROSE AND NEO-TRACE4 ALL DELIVERED AS REQUESTED WITHOUT ERROR. COMPOUNDER WAS FOUND TO FUNCTION AS INTENDED.

    Description of Event or Problem · 5

    ON (B)(6) 2010, (B)(6) HOSPITAL STAFF CALLED BAXA TECHNICAL SUPPORT TO REPORT THAT 4 PATIENTS, WHO HAD RECEIVED TPN ON (B)(6) 2010, EXPERIENCED HYPOGLYCEMIA. THE PHARMACY BELIEVED THIS WAS DUE TO A LESS THAN ANTICIPATED AMOUNT OF DEXTROSE IN THE SUBJECT TPN BAGS. THE TPNS WERE STOPPED AND ADDITIONAL DEXTROSE WAS DELIVERED TO THE PATIENTS. UPON FURTHER COMMUNICATION WITH THE CUSTOMER, THE NUMBER OF PATIENTS INVOLVED WAS INCREASED TO 5. ALL PATIENTS ARE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 2400 EXACTA-MIX 2400 LHI BAXA CORPORATION 2400-M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other
    2 UNK
    3 UNK
    4 UNK
    5 UNK