FDA Adverse Event
Injury
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 2896254
·
Received December 28, 2012
Report
- Report Number
- 1314492-2012-00552
- Event Type
- Injury
- Date Received
- December 28, 2012
- Report Date
- December 5, 2012
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED TO SIGMA FOR EVAL AND THEREFORE AN EVAL COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THIS TIME, THE DATE OF EVENT IS UNK.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT TURNED OFF A PUMP DUE TO FREQUENT ALARMS; THIS CAUSED THE IV LINE TO CLOT (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNK).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |