CADD SOLIS VIP
Report
- Report Number
- 3012307300-2022-06795
- Event Type
- Malfunction
- Date Received
- April 21, 2022
- Report Date
- October 24, 2022
- Manufacturer
- ST PAUL
- Product Code
- MEA
- UDI-DI
- 15019517099690
- PMA / PMN Number
- K170982
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE DEVICE WAS RETURNED TO SMITHS (ICU MEDICAL).
OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. THE CUSTOMERS REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION FOUND THAT THE PUMP HOUSING WAS SEPARATED DUE TO DAMAGE. THE REPORTED PROBLEM DID NOT PASS ACCURACY TEST, WAS NOT DUPLICATED. THREE ACCURACY TESTS WERE RAN, AND THE DEVICE WAS FOUND WITHIN SPECIFICATION RANGE OF ALL THREE TESTS. THUS, NO PROBLEM WAS FOUND RELATING TO ACCURACY. THE ROOT CAUSE OF THE REPORTED ISSUES WAS UNDETERMINED AS NO FAULT WAS FOUND. NO CORRECTIVE ACTION WAS TAKEN AS NO REPAIR WAS NEEDED. PRODUCT IS BEYOND A YEAR FROM MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. SERVICE REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE PREVIOUSLY.
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS NO PATIENT INVOLVEMENT; ISSUE WAS FOUND DURING PREVENTIVE MAINTENANCE.
ORACLE RO 1221668: IT WAS REPORTED THAT THE PUMP DID NOT PASS ACCURACY TESTS. PATIENT INVOLVEMENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2418309 | CADD SOLIS VIP | PUMP, INFUSION | MEA | ST PAUL | 2110 | 15019517099690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |