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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, maxzero, foreign matter identified inside the maxzero.The following was provided by the initial reporter: the picc was inserted on august 10, and bifried was administered via continuous infusion for 24 hours.Residue was discovered inside the maxzero housing on september 7.Since the patient had been experiencing fever and signs of shock for about a week prior to that, the picc was removed.Although the fever subsided after removal, the culture results from the tip, end point of the picc were negative.Therefore, it could not be definitively determined that the fever was caused by the catheter.(it is also possible that the fever subsided due to the effects of antibiotics administered after the onset of fever.) regarding the exchange frequency of the max zero, hospital policy stipulates exchange once a week, concurrently with the infusion set; however, it is unclear whether exchanges were properly performed at that frequency in this case (it is possible that it was left in place continuously).As for flushing, there is no report of any flushing being performed because the administration was continuous for 24 hours.
Event or Problem Description
Additional information: the feedback indicates that the residue was discovered inside the maxzero housing on 7 sept; however, it is unclear when the affected mz1000 was first used; please confirm which date the mz1000 was used from: - the hospital policy regarding the maximum interval between maxzero replacements is to replace them at the same time as the iv set (at least once every week); however, since there are no records indicating whether this was properly followed in this case, it is unclear (it is possible that the maxzero was never replaced after the picc was inserted).Please clarify why the user believes that the mz1000 is the cause of the observed residue: -we believe the issue stems from improper use¿possibly because the replacement was not performed correctly¿but we also believe that the max zero itself is designed in such a way that solution tends to remain even when the pulsed flash is performed correctly.
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
Additional information: section b updated with additional response from customer.

• 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: 50913800
• Report Number: 9616066-2026-02448
• Device Sequence Number: 5803712
• 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): 09/30/2026

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: 09/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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