FDA Adverse Event
Malfunction
Summary report: N
CURLIN INFUSION IV PUMP
MDR report key: 3810368
·
Received April 11, 2014
Report
- Report Number
- 1722139-2014-00093
- Event Type
- Malfunction
- Date Received
- April 11, 2014
- Date of Event
- February 27, 2014
- Report Date
- March 18, 2014
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FOUND THE PLATEN DOOR BENT DUE TO IMPACT CAUSING IT TO NOT DELIVER FLUID. PUMP'S PLATEN DOOR WAS REPLACED TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
PT SAYS THE PUMP SHOWS IT IS RUNNING BUT THERE IS NO INFUSION. THERE WAS NO PT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221530 | CURLIN INFUSION IV PUMP | INFUSION PUMP | FRN | MOOG MEDICAL DEVICES GROUP | 4000 CMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | HYDRATION |