FDA Adverse Event
Other
Summary report: N
EXACTA-MIX 2400 COMPOUNDER
MDR report key: 1837380
·
Received September 7, 2010
Report
- Report Number
- 1419106-2010-00017
- Event Type
- Other
- Date Received
- September 7, 2010
- Date of Event
- August 12, 2010
- Report Date
- August 13, 2010
- Manufacturer
- BAXA CORPORATION
- Product Code
- LHI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL CONTACT WITH USER FACILITY WAS UNSUCCESSFUL. RESULTS: ERRONEOUS DATA.
Description of Event or Problem · 1
ON (B)(6) 2010, (B)(6) CENTER'S PHARMACIST CALLED BAXA TECHNICAL SUPPORT TO REPORT THAT A PT, WHO HAD RECEIVED TOTAL PARENTERAL NUTRITION (TPN) ON (B)(6) 2010, EXPERIENCED AN ADVERSE REACTION THAT REQUIRED RESUSCITATION DUE TO AN UNEXPECTED DELIVERY OF POTASSIUM. FURTHER INFO FROM THE USER FACILITY REVEALED THAT POTASSIUM (K) PHOSPHATE INSTEAD OF SODIUM (NA) PHOSPHATE WAS DELIVERED TO THE PT. AS A RESULT, MEDICAL INTERVENTION WAS REQUIRED TO REVIVE AND STABILIZE THE PT. THE USER FACILITY STATED THAT "SEVERAL MEDICATIONS WERE ADMINISTERED TO LOWER THE POTASSIUM LEVEL" OF THE PT. AT THE TIME OF THE INITIAL REPORT, THE PT HAD RECOVERED WITH NO FURTHER SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXACTA-MIX 2400 COMPOUNDER | EXACTA-MIX 2400 | LHI | BAXA CORPORATION | 2400-M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 DA | Required Intervention |