MAUDE Adverse Event Report: Sistemas Medicos Alaris S.A de C.V. Maxzero; Set, Administration, Intravascular

Catalog Number	MZ1000
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation result: no mz1000 sample was available for investigation.The customer did not provide any lot information but reported that "a brown deposit was observed on the max zero during use on the 20th." additionally, they confirmed "the laboratory investigated it and determined it was not a bacterium, but they received a request from the director to identify what it is." although no sample was received, the customer did provide a photograph; analysis of which confirms the customer's report as a brown residue was present inside the housing of the maxzero product.Further correspondence with the customer confirmed that the residue was identified while the product was in use; however, the customer has not confirmed how long the product was in use for, nor what fluid(s) had been infused through the maxzero.The details of this feedback were forwarded to the manufacturing site; however, a definitive cause for the customer's experience could not be determined as the sample was not available for investigation.Furthermore, as no lot number was provided it has not been possible to perform a review of the production documentation for this particular product.Although a definitive cause for the customer's experience could not be determined, analysis of the photograph suggested that the contaminant was likely to be residual medication which had adhered to the housing of the maxzero during infusion.Please note, the directions for use (dfu) of the maxzero states "flush the connector after each use with normal saline or in accordance with facility protocol." in this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer advocacy feedback database indicates that this is a rare occurrence, with only a small number of similar reports identified against the mz1000 product in the past 12 months.

• 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.; 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: 50142545
• Report Number: 9616066-2026-01952
• Device Sequence Number: 9119634
• Product Code: FPA
• UDI-Device Identifier: 10885403224782
• UDI-Public: (01)10885403224782
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: MZ1000
• 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: 07/23/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown