FDA Adverse Event
Injury
Summary report: N
SIGMA MODEL SPECTRUM
MDR report key: 2081234
·
Received April 7, 2011
Report
- Report Number
- 1314492-2011-00016
- Event Type
- Injury
- Date Received
- April 7, 2011
- Report Date
- April 8, 2011
- Manufacturer
- SIGMA LLC
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE FOLLOWING INFORMATION WAS COMMUNICATED TO SIGMA FROM A DISTRIBUTOR REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED AT THE USER FACILITY: THE DIRECTOR OF MEDICAL SURGICAL DEPARTMENT STATED A NURSE MISLOADED THE ADMINISTRATION SET INTO THE SPECTRUM PUMP, WHICH CAUSED THE PUMP TO PULL BLOOD FROM THE PATIENT. THERE WAS NO PATIENT INJURY. THE PUMP SERIAL NUMBER WAS NOT RECORDED, NOR WAS IT PULLED FROM SERVICE. SIGMA HAS NOT RECEIVED ANY ADDITIONAL INFORMATION, NOR HAS THE PUMP BEEN RETURNED FOR EVALUATION. SIGMA LACKS SUFFICIENT INFORMATION TO VERIFY THE INCIDENT OR DETERMINE IF A MALFUNCTION OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGMA MODEL SPECTRUM | SPECTRUM INFUSION PUMP | FRN | SIGMA LLC | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |