MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB 2SS 0.2M CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 11532269

Device Problem Complete Blockage (1094)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no product or photo was returned by the customer.The customer complaint that there is a back check valve failure could not be verified due to the product not being returned for failure investigation.A device history record review for model 11532269 lot number 21046047 was performed.The search showed that a total of 15363 units in 1 lot number was built on (b)(6) 2021 there were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: no product will be returned per customer.No investigation was performed.

Event Description

It was reported that the as lvp 20d low sorb 2ss 0.2m cv experienced flow issues.The following information was provided by the initial reporter: event description: infusion of paclitaxel over-infused much faster than expected.The primary saline bag was reported to be bulging / with more fluid than when the infusion started; therefore, a back check valve failure is highly suspected.Patient effect: no harm reported.

• Brand Name: AS LVP 20D LOW SORB 2SS 0.2M CV
• 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: 12506978
• MDR Text Key: 272694994
• Report Number: 9616066-2021-52104
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232341
• UDI-Public: 50885403232341
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11532269
• Device Catalogue Number: 11532269
• Device Lot Number: 21046047
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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