MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D 3SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0007

Device Problem Improper Flow or Infusion (2954)

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

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: three photos were submitted for quality investigation.The customer complaint of tubing kinked was partially verified by visual inspection.Evaluation of the photos submitted indicate two kinks.One kink is located on the tubing below the drip chamber, another kink is located on the tubing with the pinch clamp.The claim of the kinked tubing causing the pumps to alarm could not be verified due to no sample being received.A device history record review for model: 2426-0007 lot number: 22079245 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13jul2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issues seen in the photos provided by the customer could not be determine because the physical samples were not available for further inspection.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

It was reported that the bd alaris¿ lvp 20d 3ss cv experienced kinked tubing.The following information was provided by the initial reporter: sets off the alarms due to the kinking in the material.

• Brand Name: BD ALARIS¿ LVP 20D 3SS 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
• 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: 15920210
• MDR Text Key: 307899534
• Report Number: 9616066-2022-01853
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2022

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 Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 22079245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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