SPECTRUM IQ
Report
- Report Number
- 1314492-2023-05028
- Event Type
- Malfunction
- Date Received
- January 12, 2024
- Date of Event
- December 20, 2023
- Report Date
- December 18, 2024
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K222048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
CORRECTION: D1: BRAND NAME, D4: MODEL #, D4: UNIQUE IDENTIFIER (UDI) #, G4: COMBINATION PRODUCT ADDITIONAL INFORMATION: H6, H11. H11: A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE HAS NO PREVIOUS SERVICE EVENTS; THEREFORE, SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE ISSUE REPORTED BY THE CUSTOMER ALIGNS WITH THE ISSUE DESCRIBED BY FA 2024-023. THE ISSUE IS RELATED TO THE BATTERY MODULE SOFTWARE, AND THE STUCK MESSAGES CONDITION DOES NOT AFFECT THE USER'S ABILITY TO PROGRAM THE DEVICE AND DOES NOT AFFECT FUNCTION OF THE DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT A SPECTRUM IQ PUMP WAS NOT SENDING STATUS MESSAGES WHILE CONTINUING TO RUN THE PROGRAMMED THERAPY. THERE WAS NO REPORT OF 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 |
|---|---|---|---|---|---|---|---|
| 2099924 | SPECTRUM IQ | PUMP, INFUSION | FRN | BAXTER HEALTHCARE CORPORATION | 3570009 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NI. |