FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
MDR report key: 1130087
·
Received August 19, 2008
Report
- Report Number
- 6000001-2008-00470
- Event Type
- Malfunction
- Date Received
- August 19, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 5, 2008
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN REQUESTED BY BAXTER FOR EVALUATION, BUT HAS NOT YET BEEN RECEIVED. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IT ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPORTED AN INFUSION PUMP THAT WAS OVERDELIVERING ON CHANNEL B. THE EVENT WAS REPORTED TO HAVE OCCURRED PRIOR TO USE. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE PTE. LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |