FDA Adverse Event
Injury
Summary report: N
COLLEAGUE CX TRIPLE CHANNEL VOLUMTRIC INFUSION PUMP
MDR report key: 1003146
·
Received February 4, 2008
Report
- Report Number
- 6000001-2008-00030
- Event Type
- Injury
- Date Received
- February 4, 2008
- Report Date
- January 22, 2008
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH MULTIPLE CALLS HAVE BEEN PLACE TO THE FACILITY REQUESTING ADDITIONAL CLINICAL INFO, NO RESPONSE HAS BEEN REC'D. SHOULD THE PUMP BE REC'D FOR EVAL, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE CX TRIPLE CHANNEL VOLUMTRIC INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE. LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |