FDA Adverse Event
Malfunction
Summary report: N
SAPPHIREPLUS INFUSION PUMP
MDR report key: 5808630
·
Received July 20, 2016
Report
- Report Number
- 3010293992-2016-00173
- Event Type
- Malfunction
- Date Received
- July 20, 2016
- Report Date
- November 14, 2016
- Manufacturer
- Q CORE MEDICAL
- Product Code
- FRN
- PMA / PMN Number
- K141389
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). EXEMPTION NUMBER, E2014005.
Additional Manufacturer Narrative · 0
(B)(4). EXEMPTION NUMBER, E2014005.
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "PRODUCT #3 - NO HARM TO PATIENT. DELIVERED AT A RATE OF 10.6 ML/HR VS. REQUESTED 6.2 ML/HR. (B)(6) IN DEPT. (B)(6). PUMP TREATMENT INFORMATION:UNKNOWN. TYPE OF DRUG:UNKNOWN. WAS THERE A PRIME PERFORMED:NO. DELAY IN THERAPY:UNKNOWN. NEED FOR MEDICAL INTERVENTION:NO. HUMAN HARM: NO".
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "PRODUCT #3 - NO HARM TO PATIENT. DELIVERED AT A RATE OF 10.6 ML/HR VS. REQUESTED 6.2 ML/HR. (B)(6) IN DEPT. T10PP. PUMP TREATMENT INFORMATION:UNKNOWN, TYPE OF DRUG:UNKNOWN, WAS THERE A PRIME PERFORMED:NO, DELAY IN THERAPY:UNKNOWN, NEED FOR MEDICAL INTERVENTION:NO, HUMAN HARM: NO."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462970 | SAPPHIREPLUS INFUSION PUMP | INFUSION PUMP | FRN | Q CORE MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |