CADD LEGACY PUMP
Report
- Report Number
- 3012307300-2022-06164
- Event Type
- Malfunction
- Date Received
- April 11, 2022
- Report Date
- August 26, 2022
- Manufacturer
- ST PAUL
- Product Code
- FRN
- UDI-DI
- 10610586019548
- PMA / PMN Number
- K982838
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WERE PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.
H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES NOT REQUIRED. D1: CORRECTION: BRAND NAME: CADD LEGACY PUMP. D2: CORRECTION: PRODUCT CODE: FRN. D2: CORRECTION: COMMON DEVICE NAME: PUMP, INFUSION. D4: CORRECTION: UDI#: (B)(4). D4: CORRECTION: CATALOG NUMBER: 21-6400-51. D4: CORRECTION: MODEL NUMBER: 6400. G5: CORRECTION: PREMARKET (510K) NUMBER: K982838. H5: CORRECTION: LABELED FOR SINGLE USE: NO.
PER MW5107258: IT WAS REPORTED THAT CADD RESERVOIR CASSETTE IS ALARMING NO DISPOSABLE, CLAMP TUBING. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2340409 | CADD LEGACY PUMP | PUMP, INFUSION | FRN | ST PAUL | 6400 | 10610586019548 | |
| 678229 | CADD LEGACY PUMP | PUMP, INFUSION | FRN | ST PAUL | 6400 | 10610586019548 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |