FDA Adverse Event
Malfunction
Summary report: N
CADD® CADD-MS® 3 AMBULATORY INFUSION PUMP
MDR report key: 7736571
·
Received July 31, 2018
Report
- Report Number
- 3012307300-2018-02946
- Event Type
- Malfunction
- Date Received
- July 31, 2018
- Date of Event
- June 28, 2018
- Report Date
- July 31, 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
- PA, 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 INTERMITTENTLY STOPPED WORKING AND THEN WOULD RESTART BACK UP AGAIN WITH NO WARNING. IT WAS NOTED THAT THIS WOULD HAPPEN SEVERAL TIMES THROUGHOUT THE DAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 577181 | CADD® CADD-MS® 3 AMBULATORY INFUSION PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 7400 | 10610586029554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR |