FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE M.T INFUSION PUMP- US
MDR report key: 5979501
·
Received September 27, 2016
Report
- Report Number
- 3010293992-2016-00213
- Event Type
- Malfunction
- Date Received
- September 27, 2016
- Report Date
- August 29, 2016
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- FRN
- UDI-DI
- 07290109150109
- PMA / PMN Number
- K123049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
DISTRIBUTOR INFORMATION: (B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4). 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
"WILL NEED REPAIRS AS PUMP'S PROGRAM CHANGED IN THE MIDDLE OF THE INFUSION ACCORDING TO PATIENT. KINDLY ACKNOWLEDGE NO PATIENT WAS INVOLVED AND NO HUMAN HARM CAUSED. NONE. WHAT SOFTWARE VERSION IS INSTALLED ON THE PUMP? R13 V2. MODE: CONTINUOUS"
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "PUMP'S PROGRAM CHANGED IN THE MIDDLE OF THE INFUSION ACCORDING TO PATIENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632405 | SAPPHIRE M.T INFUSION PUMP- US | INFUSION PUMP | FRN | Q CORE MEDICAL LTD. | 07290109150109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |