FDA Adverse Event
Other
Summary report: N
CURLIN INFUSION 4000CMS IV PUMP
MDR report key: 1680181
·
Received May 7, 2010
Report
- Report Number
- 1722139-2010-00062
- Event Type
- Other
- Date Received
- May 7, 2010
- Date of Event
- April 7, 2010
- Report Date
- May 5, 2010
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
METHOD: ACTUAL DEVICE EVALUATED. STANDARD PERFORMANCE TESTS WERE COMPLETED. VISUAL INSPECTION PERFORMED. RESULTS: USER DID NOT FOLLOW INSTRUCTIONS TO HAVE PUMP CHECKED/TESTED AFTER BEING DAMAGED/DROPPED. CONCLUSION: DEVICE FOUND TO BE DAMAGED FROM ABUSE OR BEING DROPPED. THE DEVICE PLATEN (LATCH) WAS BENT, WHICH CAUSED THE DEVICE TO HAVE A FREE FLOW CONDITION.
Description of Event or Problem · 1
REPORTED BY THE CUSTOMER AS: DID 2 DAYS OF INFUSION IN 6 HOURS. CARDIAC DRUG WAS MILRINONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN INFUSION 4000CMS IV PUMP | FRN | MOOG MEDICAL DEVICES GROUP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |