CADD® CADD-PRIZM® VIP AMBULATORY INFUSION PUMP
Report
- Report Number
- 3012307300-2018-04125
- Event Type
- Malfunction
- Date Received
- October 11, 2018
- Date of Event
- August 2, 2018
- Report Date
- January 7, 2019
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION RECEIVED THAT THIS EVENT OCCURRED DURING TESTING AND THERE WAS NO PATIENT INVOLVEMENT.
ADDITIONAL INFORMATION RECEIVED THAT THIS EVENT OCCURRED DURING TESTING AND THERE WAS NO PATIENT INVOLVEMENT.
ONE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION OF THE PUMP SHOWED THAT THE PUMP HAD A CHIPPED AIR DETECTOR AND FLUID INGRESSION. THE DEVICE EVENT LOG HAD NO RELATED FINDINGS BUT DID HAVE HIGH PRESSURE ALARM MESSAGES RECORDED. FUNCTIONAL TESTING INCLUDED USE TESTING. THE PUMP WAS POWERED ON AND AN ERROR CODE WAS DISPLAYED. THE SOFTWARE APPLICATIONS WERE REINSTALLED. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE PUMP BATTERY DOOR WAS REPLACED.
INFORMATION WAS RECEIVED INDICATING THAT THIS AMBULATORY INFUSION PUMP EXHIBITED AN ERROR CODE. IT WAS NOT SPECIFIED WHETHER OR NOT THIS OCCURRED DURING INFUSION OR INTERRUPTED THERAPY. IT WAS ALSO NOTED THAT THERE WAS AN ISSUE WITH THE PUMP'S BATTERY DOOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 798432 | CADD® CADD-PRIZM® VIP AMBULATORY INFUSION PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 6101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |