FDA Adverse Event
Malfunction
Summary report: N
CURLIN INFUSION IV PUMP
MDR report key: 3043431
·
Received March 11, 2013
Report
- Report Number
- 1722139-2013-00152
- Event Type
- Malfunction
- Date Received
- March 11, 2013
- Date of Event
- February 13, 2013
- Report Date
- February 14, 2013
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
VISUAL INSPECTION OF THE PLATEN DOOR SHOWS NO PHYSICAL DAMAGE. IT OPENS AND CLOSES AS SPECIFIED. ADMINISTRATION SET WAS INSERTED, PLATEN DOOR WAS CLOSED, AND NO FREE FLOW WAS OBSERVED. PERFORMED 40 PSI TEST AND THE PUMP PASSED THE TEST WITH NO ERRORS OR ALARMS. COMPLAINT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
CUSTOMER STATES THAT DURING TESTING PUMP CONSTANTLY FREE FLOWS WHEN CASSETTE IS ATTACHED. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102880 | CURLIN INFUSION IV PUMP | FRN | MOOG MEDICAL DEVICES GROUP | 4000 CMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |