FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
MDR report key: 1200964
·
Received October 20, 2008
Report
- Report Number
- 6000001-2007-00330
- Event Type
- Malfunction
- Date Received
- October 20, 2008
- Date of Event
- December 1, 2006
- Report Date
- December 7, 2006
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED 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 JAN 03, 2007. EVALUATION SUMMARY: THE EVALUATION WAS COMPLETED AND THE PUMP WAS TESTED FOR ACCURACY. THE CUSTOMER REPORTED CONDITION OF UNDER-INFUSING COULD NOT BE CONFIRMED DURING SERVICE TESTING.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A PUMP THAT WAS UNDER-INFUSING DURING BIO-MED TESTING. ACCORDING TO THE FACILITY REPRESENTATIVE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE CX VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE. LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |