MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20D 1CV 2SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0007

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.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the gem v/nv 20d 1cv 2ss dehp free experienced air bubbles/air in line.The following information was provided by the initial reporter: material #: 2420-0007.Batch/ lot #: unknown ( customer provided 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.

Manufacturer Narrative

H.6.Investigation: one photo was taken by the customer which verifies the complaint that there is air/bubbles in the tubing.No product was returned by the customer.The customer complaint that there is air/ bubbles in the tubing when primed could not be replicated due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported that the gem v/nv 20d 1cv 2ss dehp free experienced air bubbles/air in line.The following information was provided by the initial reporter: material #: 2420-0007, batch/ lot #: unknown ( customer provided 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 20D 1CV 2SS 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: 11996754
• MDR Text Key: 256204186
• Report Number: 9616066-2021-51309
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 37613203021020
• 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,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1