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

Model Number 2420-0500

Device Problem Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/25/2021

Event Type  malfunction  

Manufacturer Narrative

Medical 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 as lvp 20d dehp 2ss cv tubing separated below the y-port connection and leaked out medication.The following information was provided by the initial reporter: "alaris tubing infusing levophed became disconnected just below y connection port.Medication dumped onto the group and patient became hypotensive.".

Manufacturer Narrative

H.6.Investigation: the customer reported the tubing disconnected below y-port and returned the used sample.The sample was clearly separated below the y-port and the complaint is verified.Visual inspection under the microscope found the root cause to be insufficient solvent.The solvent appears to only be at the very top of the tubing, so shallow insertion depth is also a cause.There were no other failure modes observed.A device history record review could not be performed on material #2420-0500 because a valid lot number was not provided by the customer.H3 other text : see h.10.

Event Description

It was reported that the as lvp 20d dehp 2ss cv tubing separated below the y-port connection and leaked out medication.The following information was provided by the initial reporter: "alaris tubing infusing levophed became disconnected just below y connection port.Medication dumped onto the group and patient became hypotensive.".

• Brand Name: AS 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
• MDR Report Key: 11904072
• MDR Text Key: 258919881
• Report Number: 9616066-2021-51188
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: 37613203012448
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Date Manufacturer Received: 06/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1