FDA Adverse Event
Malfunction
Summary report: N
CURLIN INFUSION 6000 IV PUMP
MDR report key: 2863568
·
Received November 1, 2012
Report
- Report Number
- 1722139-2012-01114
- Event Type
- Malfunction
- Date Received
- November 1, 2012
- Date of Event
- October 1, 2012
- Report Date
- October 3, 2012
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED.
Description of Event or Problem · 1
CUSTOMER STATES THAT THE PUMP UPGRADED TO V2.01 WILL NOT RETAIN THE LOADING DOSE SET AFTER THE PROGRAM HAD BEEN CONFIRMED AND THE PUMP IS TURNED OFF AND ON AGAIN. THE PROGRAM SET REMAINS BUT THE LOADING DOSE DISAPPEARS. THE CUSTOMER TESTED THIS WITH OTHER PUMPS HAVING VERSION 6R9D AND THE LOADING DOSE VALUE IS RETAINED AFTER THE PUMP IS TURNED OFF AND ON AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN INFUSION 6000 IV PUMP | FRN | MOOG MEDICAL DEVICES GROUP | 6000 CMS IOD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |