SAPPHIRE INFUSION PUMP
Report
- Report Number
- 3010293992-2016-00164
- Event Type
- Malfunction
- Date Received
- July 7, 2016
- Date of Event
- June 15, 2016
- Report Date
- September 13, 2016
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- FRN
- PMA / PMN Number
- K123049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
(B)(4). EXEMPTION NUMBER, E2014005.
(B)(4). EXEMPTION NUMBER, E2014005.
THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): "DIRECT ANSWER, NO CALL BACK TIME. CLIENT STATES THAT HER PUMP IS ALARMING "AIR IN LINE" AND IT HAD STARTED LAST NIGHT AT 2000. CLIENT SHUT OFF PUMP AT THAT TIME AND WHEN SHE TURNED IT ON TODAY, THE SAME ALARM WENT OFF. CLIENT STATED THAT SHE WAS GOING TO SEE HER NURSE AT THE HOSPITAL IN 2 HOURS. WRITER OFFERED SUGGESTION CLIENT TO GO IN NOW INSTEAD OF IN 2 HOURS IF SHE HAD NOT HAD A DOSE SINCE LAST NIGHT. CLIENT STATED SHE WOULD DO THIS. TYPE OF DRUG:UNKNOWN. DELAY IN THERAPY:YES. NEED FOR MEDICAL INTERVENTION:NO. DEATH OR SERIOUS INJURY: NO".
THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): "DIRECT ANSWER, NO CALL BACK TIME. CLIENT STATES THAT HER PUMP IS ALARMING "AIR IN LINE" AND IT HAD STARTED LAST NIGHT AT 2000. CLIENT SHUT OFF PUMP AT THAT TIME AND WHEN SHE TURNED IT ON TODAY, THE SAME ALARM WENT OFF. CLIENT STATED THAT SHE WAS GOING TO SEE HER NURSE AT THE HOSPITAL IN 2 HOURS. WRITER OFFERED SUGGESTION CLIENT TO GO IN NOW INSTEAD OF IN 2 HOURS IF SHE HAD NOT HAD A DOSE SINCE LAST NIGHT. CLIENT STATED SHE WOULD DO THIS. TYPE OF DRUG:UNKNOWN. DELAY IN THERAPY:YES. NEED FOR MEDICAL INTERVENTION:NO. DEATH OR SERIOUS INJURY: NO."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430545 | SAPPHIRE INFUSION PUMP | INFUSION PUMP | FRN | Q CORE MEDICAL LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |