MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. ALARIS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	10011865
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
Pump alarming downstream occlusion.Piv flushed with ease, able to get blood return, iv site asymptomatic, filter changed out with new filter but same type of filter.No patient harm.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual inspection did not indicate any damages or abnormalities on the sample.The sample was then primed with not issues with leakage, air-in-line or occlusion.The sample was then connected to a sample bd infusion set and a simulated infusion was conducted.There were no issues found.The customer complaint of fluid blockage / flow issues - backflow was not confirmed.A root cause analysis was not conducted because the reported failure could not be replicated.A device history record review could not be performed because the lot number is unknown.

• Brand Name: ALARIS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24145452
• Report Number: 9616066-2026-00082
• Device Sequence Number: 21134980
• Product Code: FPA
• UDI-Device Identifier: 10885403233647
• UDI-Public: (01)10885403233647
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10011865
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown