FDA Adverse Event
Malfunction
Summary report: N
CADD PRIZM VIP PUMPS
MDR report key: 8080307
·
Received November 16, 2018
Report
- Report Number
- 3012307300-2018-08294
- Event Type
- Malfunction
- Date Received
- November 16, 2018
- Report Date
- December 27, 2018
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- PMA / PMN Number
- K000842
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ONE CADD PRIZM PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION PERFORMED AND PRODUCT FOUND TO BE IN GOOD CONDITION. CUSTOMER'S COMPLAINT OF DELIVERY ACCURACY WAS NOT REPLICATED. THE EVENT LOG DID NOT SHOW ANY RELATED ERRORS, SERVICE REPLACED THE MOTOR ASSEMBLY AND THE EXPULSOR WERE REPLACED AS A PRECAUTION. USE TESTING WAS PERFORMED. THE PROBLEM SOURCE IS UNKNOWN.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION IN PROGRESS.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD PRIZM VIP PUMP WAS OVER INFUSING. NO ADVERSE EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 918399 | CADD PRIZM VIP PUMPS | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 6101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |