Device adverse event reports (MAUDE)

Spectrum IQ · Pump, infusion

BAXTER HEALTHCARE CORPORATION · False Alarm

2026-09-30MalfunctionInitial submissionMDR 50941447

Manufacturer contact state

Manufacturer link flag

Manufacturer g1 city

MEDINA

Manufacturer contact address 1

25212 W. Illinois Route 120

Manufacturer contact pcity

+1(224)2

Event type

Malfunction

Report number

1314492-2026-02104

Product problem flag

Date received

20260930

PMA pmn number

K251636

Date of event

20260909

Reprocessed and reused flag

Manufacturer contact zip code

60073

Reporter occupation code

BIOMEDICAL ENGINEER

Manufacturer contact plocal

+1(224)270-5355

Noe summarized

Manufacturer g1 postal code

14103

Manufacturer g1 state

Reporter country code

Date added

20260930

Previous use code

Reporter state code

Mfr report type

Thirty-Day

Manufacturer contact country

Date changed

20260930

Health professional

Summary report flag

Date report

20260929

Manufacturer g1 country

Manufacturer contact city

Round Lake

MDR report key

50941447

Date manufacturer received

20260909

Report source code

Manufacturer report

Manufacturer g1 zip code

14103

Manufacturer g1 name

BAXTER HEALTHCARE - MEDINA

Adverse event flag

Single use flag

Manufacturer g1 address 1

711 PARK AVENUE

Manufacturer contact postal code

60073

Type of report

Initial submission

Source type

Health Professional, Company representation

Device

Device sequence number
87404
Date received
20260930
Brand name
Spectrum IQ
Generic name
Pump, infusion
Manufacturer d name
BAXTER HEALTHCARE CORPORATION
Manufacturer d city
DEERFIELD
Manufacturer d state
IL
Device operator
OTHER
Model number
3570009
Catalog number
3570009
Lot number
N/A
Device availability
Yes
Date returned to manufacturer
20260902
Device report product code
FRN
Device evaluated by manufacturer
Y
Combination product flag
N
UDI di
00085412610900
UDI public
(01)00085412610900
Harmonized identifiers (openFDA)
Device name
Pump, Infusion
Medical specialty description
General Hospital
Regulation number
880.5725
Device class
2

Product problems

False Alarm

Patient

Patient sequence number
1
Date received
20260930
Patient sex
Unknown
Patient problems
No Clinical Signs, Symptoms or Conditions

How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.