FDA Adverse Event
Malfunction
Summary report: N
SAPPIRE INFUSION PUMP
MDR report key: 5976464
·
Received September 26, 2016
Report
- Report Number
- 3010293992-2016-00211
- Event Type
- Malfunction
- Date Received
- September 26, 2016
- Report Date
- September 22, 2016
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- FRN
- UDI-DI
- 07290109150147
- PMA / PMN Number
- K123049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
(B)(4). EXEMPTION NUMBER, E2014005.
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "ON (B)(6) 2016, EPIDURAL PUMP VOLUME INFUSED 84.6/100 ML ON PUMP HISTORY AND BAG WAS DRY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 628249 | SAPPIRE INFUSION PUMP | INFUSION PUMP | FRN | Q CORE MEDICAL LTD. | 07290109150147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |