FDA Adverse Event
Malfunction
Summary report: N
CURLIN INFUSION 4000CMS IV PUMP
MDR report key: 1964185
·
Received December 22, 2010
Report
- Report Number
- 1722139-2010-00103
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- November 22, 2010
- Report Date
- December 22, 2010
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
METHOD: THE DEVICE WAS VISUALLY INSPECTED AND FOUND FRONT FRAME, REAR CASE POST, CRACKED BATTERY DOOR AND DEVICE RAN WITH A KNOCKING NOISE DUE TO WORN COMPONENTS. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE HISTORY LOG WILL BE EVALUATED AND MORE INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER ABOUT THE PT INVOLVED, THE MEDS INFUSED AND THE INTENDED RATE AND DOSE TO COMPARE WITH THE HISTORY LOG. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THIS INFORMATION IS OBTAINED.
Description of Event or Problem · 1
REPORTED BY THE CUSTOMER AS: NEED TO HAVE PUMP HISTORY DOWNLOADED AND SENT TO CONTACT. PT RECEIVED MORE MEDS THAN PUMP WAS PROGRAMMED FOR, POSSIBLE OPERATOR ERROR. DUE FOR ANNUAL PM. NO PATIENT INJURY.
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 | Required Intervention |