FDA Adverse Event
Malfunction
Summary report: N
CADD-LEGACY PLUS PUMP
MDR report key: 12817369
·
Received November 15, 2021
Report
- Report Number
- 3012307300-2021-11279
- Event Type
- Malfunction
- Date Received
- November 15, 2021
- Date of Event
- October 21, 2021
- Report Date
- November 15, 2021
- Manufacturer
- ST PAUL
- Product Code
- FRN
- UDI-DI
- 10610586019647
- PMA / PMN Number
- K982836
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
OTHER, OTHER TEXT: ADDITIONAL CONTACT INFORMATION: STEPHENSON CANCER CENTER, 800 NE 10TH ST STE 3100 ROOM 3049B, OKLAHOMA CITY, OK 73104, JENNIFER FITZ, [email protected]
Description of Event or Problem · 0
INFORMATION WAS RECEIVED INDICATING THAT A CADD LEGACY PLUS, MDL 6500, PUMP WAS ALARMING NO DISPOSABLE. IT WAS REPORTED THAT TROUBLESHOOTING WAS UNSUCCESSFUL. PER REPORTER RESIDUAL VOLUME WAS: 9.1 ML, RATE 2.3 AND 95.1 ML WAS GIVEN. . NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1712765 | CADD-LEGACY PLUS PUMP | INFUSION PUMP | FRN | ST PAUL | 6500 | 10610586019647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |