MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 105" ADMIN SET 20 DP, W/2 Y SITE, CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number A2-80072

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

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

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: dhr review was performed.Model: a2-80072 lot number: 20076342 qty: (b)(4) qn/deviations: zero mfg date: jul/19/2020 *no qns were found for the reported lot.Trend review: a trend review was performed for model a2-80072 and no qns related to this failure mode were found in a 12-months period (september 22nd, 2020 to september 22nd, 2021).A trend review was performed for model a2-80072 and one additional complaint (b)(4) related to this failure mode was found in a 12-months period (september 22nd, 2020 to september 22nd, 2021).Investigation summary: sample for the reported failure mode was requested, however, on september 22nd , 2021, was confirmed that no samples will be received, therefore, no investigation was performed since no samples or picture was received for evaluation and no further information regarding to the failure was provided from customer.Root cause definition: no root cause definition was determined due to the customer not providing a sample for evaluation and no further information was provided.Corrective and preventive actions: no preventive and corrective actions required since the failure mode could not be confirmed.We will continue to monitor our customer feedback processes for any similar incidences, implement any corrective actions as appropriate.

Event Description

It was reported that the 105" admin set 20 dp, w/2 y site, cv was clogged.The following information was provided by the initial reporter: stated that an administration set model a2-80072 lot 20016342 would not prime.Operator rn.Medication n/a.Patient involved.Patient was not harmed.

• Brand Name: 105" ADMIN SET 20 DP, W/2 Y SITE, 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: 12625963
• MDR Text Key: 276380389
• Report Number: 9616066-2021-52214
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020112
• UDI-Public: 00814371020112
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2023
• Device Catalogue Number: A2-80072
• Device Lot Number: 20076342
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• 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