FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM IQ
MDR report key: 23398033
·
Received October 27, 2025
Report
- Report Number
- 1314492-2025-02752
- Event Type
- Malfunction
- Date Received
- October 27, 2025
- Date of Event
- September 13, 2025
- Report Date
- December 24, 2025
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- UDI-DI
- 0085412610900
- PMA / PMN Number
- K222048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: H6, H11. H11: THE DEVICE WAS NOT RECEIVED FOR EVALUATION; 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 · 0
IT WAS REPORTED THAT A SPECTRUM IQ INFUSION PUMP INFUSED TOO SLOWLY DURING DELIVERY IN THE RHEUMATOLOGY CLINIC INFUSING IMMUNE GLOBULIN IGG GAMMAGARD LIQUID 65 G, 1000 MG/KG X 63. 8 KG IDEAL = 650 ML. 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 |
|---|---|---|---|---|---|---|---|
| 2799267 | SPECTRUM IQ | PUMP, INFUSION | FRN | BAXTER HEALTHCARE CORPORATION | 3570009 | N/A | 0085412610900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | IMMUNOGLOBULIN IGG |