MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP PS CKV 3SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 11522558

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Investigation summary: one sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with saline and the drip chamber was allowed to empty using gravity.The blue ball stopped the flow and the solution did not go past the blue ball.The customer complaint that the blue ball fell into drip chamber and air had entered the line could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 11522558 lot number 20116057 was performed.The search showed that a total of 11523 units in 1 lot number was built on 20nov2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 2 gem v/nv 20dp ps ckv 3ss dehp free experienced air in line.The following information was provided by the initial reporter: pt was receiving vincristine infusion center.Vincristine fluid complete, blue ball fell into drip chamber, air entered line.Patient received all of chemo using manual method of flushing line with saline.

• Brand Name: GEM V/NV 20DP PS CKV 3SS DEHP FREE
• 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: 12278259
• MDR Text Key: 265175263
• Report Number: 9616066-2021-51705
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232303
• UDI-Public: 50885403232303
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11522558
• Device Catalogue Number: 11522558
• Device Lot Number: 20116057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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