FDA Adverse Event
Malfunction
Summary report: N
CADD-PRIZM VIP SYSTEM
MDR report key: 8205332
·
Received December 29, 2018
Report
- Report Number
- 3012307300-2018-08931
- Event Type
- Malfunction
- Date Received
- December 29, 2018
- Report Date
- December 29, 2018
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- MEA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ONE CADD PRIZM VIP PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION PERFORMED AND PRODUCT FOUND TO BE IN GOOD CONDITION. CUSTOMER'S COMPLAINT WAS NOT VERIFIED. THE EVENT LOG DID NOT SHOW THE ERROR. THE MOTOR WILL BE REPLACED IN SERVICE AS A PREVENTATIVE MEASURE. USE TESTING WAS PERFORMED. THE PROBLEM SOURCE IS UNKNOWN.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT THE CADD PRIZM VIP PUMP HAD ERROR CODE 10037. NO REPORTED ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1044413 | CADD-PRIZM VIP SYSTEM | PUMP, INFUSION, PCA | MEA | SMITHS MEDICAL ASD, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |