MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S); INTRAVASCULAR ADMINISTRATION SET

Model Number	MFS102
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the seven bd maxguard flow controller administration set with needleless y-site(s) experienced malfunction dial.The following information was provided by the initial reporter: 7 of our home infusion patients reported that when they used the dial to set their flow rate, the medication would not flow through at all (so they would not get their doses); but when the dial is turned up to max flow rate the medication can flow through for priming.
Additional Manufacturer Narrative
H.6.Investigation summary: one sample of material number mfs102 was submitted for quality investigation.The customer complaint of clamp issue / damage related to clamp was verified by testing.Evaluation of the sample submitted started with a visual inspection of the infusion set.There were no visible issues with the tubing or components for the infusion set.The infusion set was previously primed with an unknown fluid, and was connected to a infusion bag filled with water.The flow dial was set to "open," and the infusion set was allowed to flow for 15 minutes.After the 15 minutes the infusion set dial was set to 250 ml/hr, and the outlet of the set was placed into a graduated cylinder to determine its flow rate.The infusion set was allowed to run for 1/2 hour and the amount of fluid collect was 33 ml.This equals a flow rate of 66 ml/hr.This flow rate is below the selected flow rate of 250 ml/hr.A device history record review for model mfs102 lot number 22029884 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28feb2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue seen in this complaint is that the flow control valve is not allowing for the correct flow of fluid.This issue has been seen on similar devices and previous evaluations have determined that the issue is that the gasket within the flow control valve is misaligned causing for inconsistent flow rates and sometimes complete occlusions of the infusion set.H3 other text : see h.10.
Event or Problem Description
It was reported that the seven bd maxguard flow controller administration set with needleless y-site(s) experienced malfunction dial.The following information was provided by the initial reporter: 7 of our home infusion patients reported that when they used the dial to set their flow rate, the medication would not flow through at all (so they would not get their doses); but when the dial is turned up to max flow rate the medication can flow through for priming.

• Brand Name: BD MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14713991
• Report Number: 9616066-2022-00712
• Device Sequence Number: 2235241
• Product Code: FPA
• UDI-Device Identifier: 10885403236334
• UDI-Public: 10885403236334
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/22/2022

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: Lay User/Patient
• Device Expiration Date: 02/28/2025
• Device Model Number: MFS102
• Device Catalogue Number: MFS102
• Device Lot Number: 22029884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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