MAUDE Adverse Event Report: Sistemas Medicos Alaris S.A de C.V. BD Alaris Pump Module Infusion Set; Intravascular Administration Set

Catalog Number	2204-0007
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Headache (1880)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris pump module infusion set had flow issues.The following information was provided by the initial reporter: incident report details: device: bd alaris 8015 pc unit.Serial number: (b)(6).Date of event: 29-aug-2026.Time of event: unknown.Patient involvement: yes.Patient harm: unknown.Event description: the bd alaris 8015 pc unit (s/n (b)(6)) was infusing medication to a patient.The customer reported that the medication was delivered faster than expected.The infusion was programmed to run over 1 hour, however, the infusion was reportedly completed in approximately 38 minutes.No additional information regarding the infusion setup, medication, programmed rate, volume to be infused (vtbi), alarm history, or device logs was provided at the time of reporting.
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD Alaris Pump Module Infusion Set
• Common Device Name: Intravascular Administration Set
• 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 ; +1(847)393-5694
• MDR Report Key: 50858507
• Report Number: 9616066-2026-02403
• Device Sequence Number: 9554058
• Product Code: FPA
• UDI-Device Identifier: 10885403199363
• UDI-Public: (01)10885403199363
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: Other
• Device Catalogue Number: 2204-0007
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 154 LB