MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 17 INCH EXT W/.2F 1VLV FIXED LL; INTRAVASCULAR ADMINISTRATION SET

Model Number 21028E

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

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

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: an invalid lot # of 20105199 was provided by the initial reporter.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: two samples were received for quality investigation.The customer complaint of flow issue - fluid blockage could not be verified.The extension sets were examined before testing and it was noticed that the pinch clamp on both infusion sets were engaged.The extension sets were then connected to a syringe filled with water and the water was pushed through the entire set.There were no issues when attempting to flush the extension set.The syringe was then connected to the y-site smart sites of the infusion sets to check if the smartsites were occluding.There were no flow issues - fluid blockage seen during testing.The extension sets were then connected to a sample infusion set primed and filled with normal saline.A simulated infusion was conducted with the extension sets connected to the infusion set.There were no issues indicated by the alaris pump, and fluid flowed through both extension sets.A device history record review could not be performed on model 21028e because an invalid lot number was provided by the customer.The root cause for this complaint could not be established because the failure mode reported could not be replicated.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.The root cause for this complaint could not be established because the failure mode reported could not be replicated.

Event Description

It was reported that 2 17 inch ext w/.2f 1vlv fixed ll experienced flow issues and were clogged.The following information was provided by the initial reporter: it was reported by the customer that they are experiencing quality issue.We are having a serious quality issue in our nicu.

• Brand Name: 17 INCH EXT W/.2F 1VLV FIXED LL
• 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
• MDR Report Key: 12639594
• MDR Text Key: 276642815
• Report Number: 9616066-2021-52243
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234963
• UDI-Public: 50885403234963
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21028E
• Device Catalogue Number: 21028E
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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