FDA Adverse Event
Malfunction
Summary report: N
SYNDEO SYRINGE PUMP
MDR report key: 1212444
·
Received October 29, 2008
Report
- Report Number
- 6000001-2007-88922
- Event Type
- Malfunction
- Date Received
- October 29, 2008
- Date of Event
- June 1, 2007
- Report Date
- June 21, 2007
- Manufacturer
- BAXTER HEALTHCARE (SG)
- Product Code
- FRN
- PMA / PMN Number
- K926385
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 20, 2007. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION, HOWEVER EVALUATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED "POSSIBLE OVERINFUSION" DURING PATIENT USE. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNDEO SYRINGE PUMP | 80FRN | FRN | BAXTER HEALTHCARE (SG) | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |