MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC 20DP W/SS DC LOW SORB; INTRAVASCULAR ADMINISTRATION SET

Model Number 10014881

Device Problem Leak/Splash (1354)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one photo of secondary set, model 10014881, was received by the customer for investigation.Upon visual inspection, it could be observed that the set's drip chamber was disconnected from the tubing.No other defects were observed.The customer's complaint that tubing disconnected from the drip chamber was verified.A device history record review for model 10014881 lot number 21069687 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16jun2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Since no physical sample was received, an investigation could not be performed and a root cause could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

It was reported that sec 20dp w/ss dc low sorb had the components separate.The following information was provided by the initial reporter: "it was reported by customer that the tubing was connected to a bag of oxaliplatin in d5w, and disconnected from the drip chamber as soon as it was hung.".

• Brand Name: SEC 20DP W/SS DC LOW SORB
• 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: 12674553
• MDR Text Key: 277889891
• Report Number: 9616066-2021-52276
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403221932
• UDI-Public: 50885403221932
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10014881
• Device Catalogue Number: 10014881
• Device Lot Number: 21069687
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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