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

Model Number MFS132

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported maxguard flow controller administration set had flow issues.The following information was provided by the initial reporter: "controller for flow was locked open.Could not adjust.".

Manufacturer Narrative

H.6.Investigation: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - accuracy with lot #21045520 regarding item #mfs132.One sample (model #mfs132) was returned by the customer.It was reported that the flow was locked open and could not be adjusted.The returned set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was successfully primed.The flow controller on the set was attempted to be adjusted, but was unable to be moved out of the "open" position.The customer complaint can be verified.A quality notification has been sent to the manufacturer and the supplier, and the sample has been sent for further investigation.The root cause of the issue was identified to be an excess of solvent applied in the joint tubing to the flow controller during the manufacturing process, resulting in the flow controller being unable to be adjusted.A quality alert was performed by the quality engineer - post market support and was communicated to production personnel to reinforce the correct assembly of the joint tubing/flow controller in model #mfs132.A device history record review for model mfs132 lot number 21045520 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

It was reported maxguard flow controller administration set had flow issues.The following information was provided by the initial reporter: "controller for flow was locked open.Could not adjust".

• Brand Name: MAXGUARD FLOW CONTROLLER ADMINISTRATION SET
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12562642
• MDR Text Key: 274282577
• Report Number: 9616066-2021-52148
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403236417
• UDI-Public: 50885403236417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MFS132
• Device Catalogue Number: MFS132
• Device Lot Number: 21045520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1