FDA Adverse Event
Malfunction
Summary report: N
CADD SOLIS VIP
MDR report key: 14250294
·
Received April 29, 2022
Report
- Report Number
- 3012307300-2022-07187
- Event Type
- Malfunction
- Date Received
- April 29, 2022
- Report Date
- March 20, 2023
- Manufacturer
- ST PAUL
- Product Code
- FRN
- UDI-DI
- 10610586019647
- PMA / PMN Number
- K982836
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL.
Additional Manufacturer Narrative · 0
OTHER TEXT: THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#(B)(4). THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.
Additional Manufacturer Narrative · 0
OTHER, OTHER TEXT: B5: ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL/ICU ON 09-MAY-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: THIS EVENT DID NOT HAPPEN WHILE THE DEVICE WAS IN USE WITH A PATIENT. THE ISSUE WAS FOUND DURING PRECHECK OF EQUIPMENT.
Description of Event or Problem · 0
ORACLE RO 1223211: ERROR CODE 1210 OCCURRED. PATIENT INVOLVEMENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57610 | CADD SOLIS VIP | PUMP, INFUSION | FRN | ST PAUL | 6500 | 10610586019647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |