FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
MDR report key: 1173665
·
Received September 25, 2008
Report
- Report Number
- 6000001-2007-06038
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- April 3, 2007
- Report Date
- April 3, 2007
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON MAY 01 2007. EVALUATION SUMMARY:THE PUMP WAS EVALUATED BY A BAXTER SERVICE TECHNICIAN. THE REPORTED CONDITION WAS CONFIRMED.
Description of Event or Problem · 1
THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE TESTING, THE BAXTER REPAIR TECHNICIAN REPORTED AN OVERINFUSION. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLO-GARD 6201 VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |