FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
MDR report key: 1193069
·
Received October 13, 2008
Report
- Report Number
- 6000001-2007-03267
- Event Type
- Malfunction
- Date Received
- October 13, 2008
- Date of Event
- January 23, 2007
- Report Date
- January 23, 2007
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- 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 FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JAN 29, 2007. EVALUATION SUMMARY: THE CONDITION OF UNDERDELIVERY WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THIS WAS CAUSED BY A FAULTY PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED.
Description of Event or Problem · 1
THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE TESTING, THE BAXTER REPAIR TECHNICIAN REPORTED THAT THE DEVICE UNDER DELIVERED.
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 |