FDA Adverse Event
Other
Summary report: N
EXTENSION SET
MDR report key: 225014
·
Received May 20, 1999
Report
- Report Number
- 6000001-1999-00294
- Event Type
- Other
- Date Received
- May 20, 1999
- Date of Event
- April 2, 1999
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FPA
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
PER USER FACILITY REPORT: "NURSE SET UP FEEDING TUBE TO INFANT AT 15:30, INFANT WAS ALSO RECEIVING MEDICATIONS THROUGH AN IV LINE. AT 16:30 THE AFTERNOON NURSE FOUND MILKY SOLUTION IN THE MEDICATION IV-LINE. PT WAS HAVING BRADYCARDIA AND THE HOUSE OFFICER WAS CALLED. HE PLACED THE INFANT ON A VENTILATOR. THE PT WAS TAKEN OFF THE VENTILATOR IN 2 DAYS. PT HAS NO SYMPTOMS STEMMING FROM THE EVENT." PT IS A 26 DAY OLD MALE, WEIGHING 4 POUNDS. "NO MORE INFO AVAILABLE." **ADDITIONAL INFO RECEIVED--THE REPORTING ACCOUNT STATES THAT THE REPORTED DEVICE IS NOT "USER FRIENDLY." THE SET CAN EASILY BE CONFUSED WITH THE FEEDING TUBE THEY UTILIZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTENSION SET | EXTENSION SET | FPA | BAXTER HEALTHCARE CORP | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |