MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 3SS 2CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 11171447

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 20d 3ss 2cv was cracked and leaked.The following information was provided by the initial reporter: material no: 11171447, batch no: unknown.It was reported that tubing cracked and leaked inside the alaris pump, and the patient was not being anti-coagulated.Event description per email states: "patient was receiving continuous infusion of heparin.The tubing cracked inside the alaris pump, which meant the patient was not being anticoagulated (a safety event was entered,) and also fluid was free flowing inside the pump, which damaged the alaris channel.".

• Brand Name: AS LVP 20D 3SS 2CV
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10775287
• MDR Text Key: 214400208
• Report Number: 9616066-2020-20240
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021242
• UDI-Public: 37613203021242
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11171447
• Device Catalogue Number: 11171447
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other