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

Model Number 10942011

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one photo of primary set, model 10942011, was received by the customer for investigation.Upon visual inspection, it could be observed that there was a significant amount of air in the tubing.No other defects were observed.The customer's complaint that there is air/ bubbles in the tubing when primed was verified.A device history record review for model 10942011 lot number 20116952 was performed.The search showed that a total of 11,523 units in 1 lot number was built on 27nov2020.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, a full 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: since no physical sample was received, a full investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that the gem v/nv 20dp dehp free experienced air bubbles/air in line.The following information was provided by the initial reporter: material #: 10942011.Batch/ lot #: 20116952.Rn noticed that bd alaris pump infusion set develops air in tubing when primed and increase in air bubbles.Not all the air comes out when attempt to flick at it, and even when primed further, there seems to be more air.The tubing seems different than what we used to use, and below a joint in the tubing is where the air and bubbles happen.Air in line.Rn states when priming, finds air under the connection.Even with flicking, the air does not fully dissipate.There also seems to be in increase in small air bubbles that cause the pump to alarm more often.

• Brand Name: GEM V/NV 20DP 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12013309
• MDR Text Key: 263492639
• Report Number: 9616066-2021-51325
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232402
• UDI-Public: 50885403232402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/27/2023
• Device Model Number: 10942011
• Device Catalogue Number: 10942011
• Device Lot Number: 20116952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2020
• 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