MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP BLD180M 15D SS; INTRAVASCULAR ADMINISTRATION SET

Model Number 2477-0007

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2020

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that as lvp bld180m 15d ss leaked.The following information was provided by the initial reporter: event 1: material #: 2477-0007 lot#: unknown it was reported that the tubing leaked around the top of the drip chamber.Verbatim: second unit of blood was infusing and almost finished and several drops of blood leaked out around the top of the drip chamber.The tubing was not being pulled or stretched.

Event Description

It was reported that as lvp bld180m 15d ss leaked.The following information was provided by the initial reporter: event 1: material#: 2477-0007, lot#: unknown.It was reported that the tubing leaked around the top of the drip chamber.Second unit of blood was infusing and almost finished and several drops of blood leaked out around the top of the drip chamber.The tubing was not being pulled or stretched.

Manufacturer Narrative

H.6.Investigation: no photo or sample was received for investigation.The customer's complaint of leakage could not be verified.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, the root cause of this failure remains unknown.

• Brand Name: AS LVP BLD180M 15D SS
• 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 22244 ; MX 22244
• MDR Report Key: 11092373
• MDR Text Key: 224807291
• Report Number: 9616066-2020-20682
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203019478
• UDI-Public: 37613203019478
• Combination Product (y/n): N
• PMA/PMN Number: K894842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2477-0007
• Device Catalogue Number: 2477-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1