FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM IQ INFUSION PUMP
MDR report key: 10886850
·
Received November 23, 2020
Report
- Report Number
- 1314492-2020-04093
- Event Type
- Malfunction
- Date Received
- November 23, 2020
- Date of Event
- October 23, 2020
- Report Date
- November 23, 2020
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K173084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM IQ PUMP HAD A RED SYSTEM ERROR ALARM (NOT SPECIFIED) DISPLAY ON THE SCREEN WITH NO AUDIBLE ALARM TONE DURING PATIENT INFUSION. THE MEDICATION BEING INFUSED AT THE TIME WAS 4MG/250CC NOREPINEPHRINE AT 0.08 MCG/KG/M IN THE MEDICAL INTENSIVE CARE UNIT (MICU) AND THAT 35.4 CC/HR WAS BEING INFUSED AS PATIENT WEIGHT WAS 118KG. THERE WAS NO KNOWN PATIENT INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1347799 | SPECTRUM IQ INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |