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

Catalog Number	2200-0500
Medical Device Problem Codes	Complete Blockage (1094); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that as lvp 20d dehp leaked and had flow issues.The following information was provided by the initial reporter: infusion line didn't clamp automatically when it was removed from pump.Detailed incident description: nurse removed line from pump.It didn't clamp automatically.Line continued to free flow.Nurse was able to replicate the incident once more with the same line, but couldn't do it again a third time, so incident appears to be intermittent.

• Brand Name: AS LVP 20D DEHP
• Common Device Name: 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: 11682600
• Report Number: 9616066-2021-50751
• Device Sequence Number: 14326440
• Product Code: FPA
• UDI-Device Identifier: 07613203012638
• UDI-Public: 07613203012638
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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
• Operator of Device: Other
• Device Catalogue Number: 2200-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1