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

Catalog Number 2420-0500

Device Problems Volume Accuracy Problem (1675); Improper Flow or Infusion (2954); Air/Gas in Device (4062)

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

Event Date 10/29/2022

Event Type  malfunction  

Manufacturer Narrative

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 that the bd alaris¿ lvp 20d dehp 2ss cv bag was almost empty when it was supposed to have infused over 4 hours.The following information was provided by the initial reporter: another nurse noticed approximately 15 minutes after medication was hung that the bag was almost empty when it was supposed to have infused over 4 hours.

Event Description

It was reported that the bd alaris¿ lvp 20d dehp 2ss cv bag was almost empty when it was supposed to have infused over 4 hours.The following information was provided by the initial reporter: another nurse noticed approximately 15 minutes after medication was hung that the bag was almost empty when it was supposed to have infused over 4 hours.

Manufacturer Narrative

Imdrf annex f grid: f23.Imdrf annex a grid: a1405, a1415.

• Brand Name: BD ALARIS¿ LVP 20D DEHP 2SS 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: 16117806
• MDR Text Key: 308583447
• Report Number: 9616066-2022-02154
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 07613203012430
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1