FDA Adverse Event
Malfunction
Summary report: N
CADD - SOLIS AMBULATORY INFUSTION PUMP
MDR report key: 3080684
·
Received April 8, 2013
Report
- Report Number
- 2183502-2013-00137
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 1, 2013
- Report Date
- April 5, 2013
- Manufacturer
- SMITHS MEDICAL MD
- Product Code
- MEA
- PMA / PMN Number
- K040899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATED THE PUMP ALARMED "ERROR CODE 44510." NO PT INJURY OR ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142631 | CADD - SOLIS AMBULATORY INFUSTION PUMP | MEA - PUMP, INFUSION, PCA | MEA | SMITHS MEDICAL MD | 2111 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NONE |