FDA Adverse Event
Malfunction
Summary report: N
CADD-PRIZM VIP SYSTEM
MDR report key: 8192513
·
Received December 21, 2018
Report
- Report Number
- 3012307300-2018-08872
- Event Type
- Malfunction
- Date Received
- December 21, 2018
- Report Date
- February 5, 2019
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- MEA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION RECEIVED ON 31 JANUARY 2019 THAT THERE WAS NO PATIENT INVOLVEMENT DURING EVENT. DEVICE EVALUATION SUMMARY: ONE CADD PRIZM VIP PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION OF THE PUMP FOUND NO PHYSICAL DAMAGE TO THE PUMP. THE REPORTED EVENT WAS FOUND IN DEVICE EVENT LOG. 061> ERROR DETECTED 10036 16:50 (B)(6) 2018 FUNCTIONAL TESTING INCLUDED USE TESTING. THE PUMP WAS POWERED UP AND NO ERROR CODE WAS OBSERVED. THE CUSTOMER REPORTED EVENT COULD NOT BE DUPLICATED. BASED ON THE HISTORY LOG EVIDENCE, THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT THE CADD PRIZM VIP PUMP HAD ERROR CODE 10036. NO REPORTED ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1029517 | CADD-PRIZM VIP SYSTEM | PUMP, INFUSION, PCA | MEA | SMITHS MEDICAL ASD, INC. | 6101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |