FDA Adverse Event
Malfunction
Summary report: N
CADD® CADD-MS® 3 AMBULATORY INFUSION PUMP
MDR report key: 7782359
·
Received August 14, 2018
Report
- Report Number
- 3012307300-2018-03081
- Event Type
- Malfunction
- Date Received
- August 14, 2018
- Report Date
- August 14, 2018
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- UDI-DI
- 10610586029554
- PMA / PMN Number
- K051568
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ONE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. FUNCTIONAL TESTING INCLUDED USE TESTING. WHILE TESTING, IT WAS FOUND THAT THE PRINTED WIRE ASSEMBLY (PWA) BOARD WAS NOT FUNCTIONING PROPERLY. THE PWA BOARD WAS REPLACED. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE AN INOPERABLE PWA BOARD.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED INDICATING THAT THIS AMBULATORY INFUSION PUMP EXHIBITED OVER INFUSION. IT WAS NOTED THAT THE PUMP ALARMED "LOW CARTRIDGE" 4 HOURS EARLIER THAN EXPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624150 | CADD® CADD-MS® 3 AMBULATORY INFUSION PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 7400 | 10610586029554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |