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

Catalog Number	MZX5306
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported disconnection.Verbatim: patient had an iv with this max zero extension set attached.They were in the middle of a procedure, covered under a sterile drape, when the max zero came disconnected from the extension set leaving the tube of the extension set entirely opened which led to 300ml blood loss from patient.Patient moved to ocu for monitoring due to blood volume lost.Ended up being ok.
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.
Additional Manufacturer Narrative
Photo taken by customer confirms the separation of the maxzero.The exact root cause could not be determined since no sample was returned.However, a separation between female luer and max zero could be related to an incorrect screwed in between components and not use proper the fixture to verify that the components were correctly assembled by the assembler as established in the work instructions.No corrective or preventive actions were taken since the root cause no being evident, however, a quality alert was created on february 13th, 2026 to communicate the complaint to the production personnel and reinforce the correct follow up to work instructions and use of fixtures.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: MAXZERO
• 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.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24209113
• Report Number: 9616066-2026-00164
• Device Sequence Number: 9635228
• Product Code: FPA
• UDI-Device Identifier: 10885403463792
• UDI-Public: (01)10885403463792(17)280901(10)25095062
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171957
• 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): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MZX5306
• Device Lot Number: 25095062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown