FDA Adverse Event
Malfunction
Summary report: N
CADD
MDR report key: 13861210
·
Received March 23, 2022
Report
- Report Number
- 3012307300-2022-05049
- Event Type
- Malfunction
- Date Received
- March 23, 2022
- Date of Event
- December 22, 2021
- Report Date
- August 4, 2022
- Manufacturer
- ST PAUL
- Product Code
- FPA
- PMA / PMN Number
- K040636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. NO LOT NUMBER PROVIDED FOR DHR.
Additional Manufacturer Narrative · 0
CORRECTION: BRAND NAME: CADD .CORRECTION: PMA/501(K): K040636.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT REPORTS NO DISPOSABLE ALARM ON BOTH CADD LEGACY PUMPS WHILE USING REMODULIN IV PRE-FILLED CASSETTE NUMBER 3 FROM (B)(6) 2021 SHIPMENT. ALARM RESOLVED BY CHANGING CASSETTES ON PUMP. PATIENT IS CONCERNED THAT SHE WILL HAVE TO MIX STATING THAT SHE GETS SO CONFUSED DUE TO DEMENTIA. FIELD NURSE GOING TO ASSIST. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863648 | CADD | SET, ADMINISTRATION, INTRAVASCULAR | FPA | ST PAUL | K040636 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |