FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
MDR report key: 1051219
·
Received May 23, 2008
Report
- Report Number
- 6000001-2008-00341
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 21, 2008
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN REQUESTED BY BAXTER FOR EVAL BUT HAS NOT YET BEEN RECEIVED. SHOULD THE PUMP BE RECEIVED FOR EVAL, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVAL OR IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
A BAXTER FIELD SERVICE ENGINEER REPORTED AN INFUSION PUMP THAT WAS NOT DETECTING AIR (FAILURE TO ALARM) ON CHANNEL B. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING BIOMEDICAL TESTING. ACCORDING TO THE HOSPITAL REP, NO PT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADD'L INFO 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 |