FDA Adverse Event
Malfunction
Summary report: N
CADD PRIZM VIP PUMPS
MDR report key: 8075028
·
Received November 15, 2018
Report
- Report Number
- 3012307300-2018-08290
- Event Type
- Malfunction
- Date Received
- November 15, 2018
- Report Date
- January 11, 2019
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- PMA / PMN Number
- K000842
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE EVALUATION- THE RETURNED DEVICE WAS GIVEN FUNCTIONAL AND DELIVERY TESTING. THE DEVICE WAS FOUND TO MEET WITH SPECIFICATIONS DURING TESTING. THE EVENT HISTORY LOG WAS DOWNLOADED AND EXAMINED; THIS SHOWED AN ERROR ALARM 10037 HAD OCCURRED; THIS TYPE OF ERROR MAY INDICATE A MOTOR PROBLEM. THE MOTOR WAS REPLACED AS A PREVENTIVE MEASURE BUT NO PROBLEMS WERE IDENTIFIED DURING TESTING.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION IN PROGRESS.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT DURING REPAIRED OF THIS SMITHS MEDICAL CADD PRIZM VIP PUMP, THE PUMPS EXHIBITED ERROR CODE LEC 10037. NO ADVERSE EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 915371 | CADD PRIZM VIP PUMPS | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 6101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |