FDA Adverse Event
Malfunction
Summary report: N
CADD
MDR report key: 12849916
·
Received November 21, 2021
Report
- Report Number
- 3012307300-2021-11592
- Event Type
- Malfunction
- Date Received
- November 21, 2021
- Report Date
- May 5, 2023
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- UDI-DI
- 15019517126587
- PMA / PMN Number
- K111275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative · 0
OTHER, OTHER TEXT: THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). PLEASE DISREGARD THE INITIAL REPORT SUBMITTED WITH THE MFR NUMBER: 3012307300-2021-11592. THE REPORT WAS SUBMITTED IN ERROR. DUPLICATE OF 3012307300-2022-01162 (CC-0123197).
Description of Event or Problem · 0
INFORMATION WAS RECEIVED INDICATING THAT THIS SMITHS MEDICAL CADD SOLIS VIP PUMP EXHIBITED EC 45639 AND RED DISPLAY WHEN TURNED ON. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1747774 | CADD | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 2120 | 15019517126587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |