FDA Adverse Event
Death
Summary report: N
AUTOMIX 3+3/AS COMPOUNDER
MDR report key: 555957
·
Received November 18, 2004
Report
- Report Number
- 6000001-2004-01852
- Event Type
- Death
- Date Received
- November 18, 2004
- Date of Event
- September 1, 2004
- Report Date
- October 22, 2004
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- LHI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS ONE INCIDENT IN WHICH THE PT EXPERIENCED HYPERBILIRUBINEMIA AND ABNORMAL LIVER FUNCTION TESTS AFTER RECEIVING TPN SOLUTION COMPOUNDED BY THE AUTOMIX COMPOUNDER. MEDWATCH REPORT REC'D FROM FACILITY INDICATES THE PT WAS DIAGNOSED WITH MALABSORPTION AT BIRTH AND HAS BEEN TPN DEPENDENT FOR LIFE. IN FEBRUARY, 2004 PT WAS ADMITTED TO THE HOSPITAL TO RULE OUT LINE INFECTION AND DEVELOPED DIC. THEIR LIVER FUNCTION TESTS WERE SLIGHTLY ELEVATED AT THAT TIME, HOWEVER, IN JULY 2004 THEY BECAME EXTREMELY ELEVATED AND PROGRESSIVELY WORSENED. THE PT SUBSEQUENTLY EXPIRED, HOWEVER, THE REPORTING FACILITY HAS NOT ASSOCIATED THE PT DEATH WITH THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOMIX 3+3/AS COMPOUNDER | I.V. SOLUTION COMPOUNDER | LHI | BAXTER HEALTHCARE CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Death | BAXTER PRODUCTS: 6060-SABRATEK 6060 HOMERUN| LOT NUMBERS 118837, 119011, 119106, 120989,121353.| LOT NUMBERS NR67294, 1017418, 1017425,| 2B6023- 20% INTRALIPIDS 2004,| C605386, C602938, C604157, C614875.| 1017565, 1017418, 1018274, 1017783, 1018598,| LOT NUMBERS C595926, C609271, C611079.| B. BRAUN: TROPHAMINE-2004.| 1018320, 1017783, 1018320. 2B0114-70%| DEXTROSE 2004-LOT NUMBERS C596486,| 2B0306-STERILE WATER FOR INJECTION 2004,| PUMP-2004-UNK. 2A9008-INFUVITE MULTIVITAMIN 2004,| MFR UNK: ZANTAC-2004. |