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 Problem Material Separation (1562)

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

Event Date 01/22/2023

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.

Event Description

It was reported that the bd alaris¿ lvp 20d dehp 2ss cv ripped apart when opening door of iv pump.The following information was provided by the initial reporter: iv tubing ripped apart when opening door of iv pump at the bottom of the part that goes into the pump under clamp.

Manufacturer Narrative

H6: investigation summary: one sample was received and investigated by our quality team.The customer's complaint of separation was immediately verified due to the tubing being separated below the blue clip portion that is inserted into the pump.After visual analyses using a high power digital microscope- there was evidence of lack of solvent which was then confirmed by the manufacturer.The root cause of this separation was improper application of solvent during the assembly of the tubing to blue clip portion of set.A device history record review for model 2420-0500 lot number 22093186 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.H3 other text : see h10.

Event Description

It was reported that the bd alaris¿ lvp 20d dehp 2ss cv ripped apart when opening door of iv pump.The following information was provided by the initial reporter: iv tubing ripped apart when opening door of iv pump at the bottom of the part that goes into the pump under clamp.

• 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 ; 8448235433
• MDR Report Key: 16427275
• MDR Text Key: 310060710
• Report Number: 9616066-2023-00244
• 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: 02/23/2023

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 Catalogue Number: 2420-0500
• Device Lot Number: 22093186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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