MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D 2SS CV L; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2420-0007

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

It was reported by the customer that the bd alaris¿ lvp 20d 2ss cv leaked near the upper fitment due to a fear.The following information was provided by the initial reporter: isd - during functional testing of the returned set received with the suspect device it was observed that the silicone segment had a leak near the upper fitment due to a tear.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported by the customer that the bd alaris¿ lvp 20d 2ss cv leaked near the upper fitment due to a fear.The following information was provided by the initial reporter: isd - during functional testing of the returned set received with the suspect device it was observed that the silicone segment had a leak near the upper fitment due to a tear.

Manufacturer Narrative

The following fields were updated due to corrections: d.9.Device available for eval?: yes, returned to manufacturer on: 03-nov-2022.Investigation summary: a sample was received for investigation.Through visual inspection, the customer complaint was confirmed.Two tears in the pumping segment could be seen more towards the center of the tubing.Only a section of the set was returned.A device history record review could not be performed on model 2420-0007 because the lot number is unknown.The manufacturing plant was notified of this defect.This failure mode is not related to manufacturing issue.The root cause was determined to be misloading of the pumping segment.If the pumping segment is not loaded from the top to bottom it can create these tears.Please contact to clinical team for follow-up.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD ALARIS¿ LVP 20D 2SS CV L
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15802695
• MDR Text Key: 307672979
• Report Number: 9616066-2022-01743
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 07613203021012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Death