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

Catalog Number	MP1000 CHINA
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation result:\ a mp1000 china product was not available for investigation; however, the customer confirmed that the complaint sample was from lot 25085182.The feedback provided by the customer states that, \"a crack formed at the connection between the needle-free connector and the infusion set during an iv infusion, causing fluid leakage\".No further information was available to assist the investigation in this instance.\ \ the details of this feedback were forwarded to the manufacturing site for investigation, where a review of the production records for lot 25085182 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.\ \ the root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.\ \ 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 feedback database indicates that this is a rare occurrence with a small number of similar reports against the mp1000 china products in the past 12 months.
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
No additional information.
Event or Problem Description
It was reported, maxplus, crack, causing leak.\ \ the following was provided by the initial reporter: a crack formed at the connection between the needle-free connector and the infusion set during an iv infusion, causing fluid leakage.

• Brand Name: Maxplus
• 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 22244
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50854718
• Report Number: 9616066-2026-02402
• Device Sequence Number: 9497737
• Product Code: FPA
• UDI-Device Identifier: 10885403223228
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: MP1000 CHINA
• Device Lot Number: 25085182
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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