FDA Adverse Event
Malfunction
Summary report: N
CURLIN INFUSION 6000 PUMP
MDR report key: 2844993
·
Received October 24, 2012
Report
- Report Number
- 1722139-2012-01058
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- December 23, 2010
- Report Date
- July 5, 2011
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Removal / Correction Number
- Z-1867-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FOUND PUMP EXPERIENCED ERROR CODE 36. NEW PUMP SOFTWARE WAS INSTALLED. (B)(4).
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES PUMP EXPERIENCED ERROR CODE 36.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN INFUSION 6000 PUMP | FRN | MOOG MEDICAL DEVICES GROUP | CMS IOD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |