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

Model Number 2420-0007

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Fda notified?: the initial reporter also notified the fda on (date) via medwatch # 2900450000-2020-8005.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.Fda device problem code: 1094, 1248, fda patient problem code: 2199.

Event Description

It was reported that the as lvp 20d 2ss cv had an occlusion in the line that caused the alarm to generate.The following information was provided by the initial reporter: "tubing was primed and inserted into alaris pump.Pump alarmed occlusion.A different pump was used and the same occlusion alarm was generated by the pump.Iv tubing was changed and worked correctly in the same pump.".

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.It was reported that there was a possible occlusion in the the iv tubing.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2420-0007 because an invalid lot number was provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that the as lvp 20d 2ss cv had an occlusion in the line that caused the alarm to generate.The following information was provided by the initial reporter: "tubing was primed and inserted into alaris pump.Pump alarmed occlusion.A different pump was used and the same occlusion alarm was generated by the pump.Iv tubing was changed and worked correctly in the same pump.".

• Brand Name: AS LVP 20D 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 22244 ; MX 22244
• MDR Report Key: 11102406
• MDR Text Key: 224797111
• Report Number: 9616066-2020-20700
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 37613203021020
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR