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

Catalog Number RG-1

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 02/19/2023

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: ta210373 was reported, however, this is not a lot # manufactured for the reported catalog #.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd flow controller over infusion occurred.There was no report of patient impact.The following information was provided by the initial reporter: the substance does not regulate the passage of the solution properly.The solution runs out before the end of the scheduled time, as it was tested with 500 ml at 250 ml / h, and the solution ran out within an hour and a half instead of two hours.

Manufacturer Narrative

H6: investigation summary: a rg-1 product was not available for investigation; however the customer confirmed that the complaint sample was from lot ta210373.The customer indicates that the infusion was completed in one and a half hours instead of the expected two hours.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot ta210373 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.During previous testing it has been confirmed that the rate indicated on the graduated scale of the tutodrop component may differ from the rate being set by the customer.As stated in the directions for use box insert ¿warnings: the i.V.Fluid container must be suspended approximately 80cm above the patient¿s mid-auxiliary line.The graduated scale is indicative and serves as a guide.The flow rate must be verified by counting drops and the flow controller adjusted until the correct rate is obtained.Avoid setting the flow controller too close to the open position since the flow rate could increase sharply¿.It is important that these instructions are adhered to in order to achieve optimum performance.The scale on the tutodrop should not be used alone to set the rate of the device.During previous testing of tutodrop products it has been confirmed that when the infusion rate is set by counting the number of drops per minute, the rate accuracy does not significantly drift over time.Please note that the tutodrop is designed for use with gravity infusions.The tutodrop allows a more consistent flow than a standard roller clamp as flow rate drift is improved when compared to a standard roller clamp.As with all gravity infusions, it is important that the flow rate is checked by counting the drops during set-up and at regular intervals after this.As with all gravity infusions the flow rate will be influenced by multiple factors including: the head-height of the bag, changes in the bag head-height during an infusion, the size of the cannula, positioning of the cannula, type/viscosity of the fluid, size and condition of the vein, fluid temperature, etc.A high degree of accuracy is not guaranteed when infusing by gravity.If a high degree of flow rate accuracy is required, the user should consider a flow-controlling infusion pump.

Event Description

It was reported while using bd flow controller over infusion occurred.There was no report of patient impact.The following information was provided by the initial reporter: the substance does not regulate the passage of the solution properly.The solution runs out before the end of the scheduled time, as it was tested with 500 ml at 250 ml / h, and the solution ran out within an hour and a half instead of two hours.

• Brand Name: BD EXTENSION SET FLOW CONTROLLER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16531180
• MDR Text Key: 311581325
• Report Number: 9616066-2023-00432
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: RG-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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