FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE M.T INFUSION PUMP- US
MDR report key: 8481952
·
Received April 4, 2019
Report
- Report Number
- 3010293992-2019-00037
- Event Type
- Malfunction
- Date Received
- April 4, 2019
- Date of Event
- March 5, 2019
- Report Date
- March 5, 2019
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- FRN
- UDI-DI
- 07290109150109
- PMA / PMN Number
- K161667
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 0
(B)(6). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL. EXEMPTION NUMBER, E2014005.
Additional Manufacturer Narrative · 0
DISTRIBUTOR INFORMATION: ICU MEDICAL, INC. US SERVICE CENTER SAN JOSE, CA 95138. EXEMPTION NUMBER: E2014005. Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL.
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: OVER DELIVERY OF MORPHINE.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA: DELIVERY ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277237 | SAPPHIRE M.T INFUSION PUMP- US | INFUSION PUMP | FRN | Q CORE MEDICAL LTD. | 07290109150109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |