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

Catalog Number 11522558

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the as lvp 20d 3ss cv bv experienced air bubbles/air in line.The following information was provided by the initial reporter: material no: 11522558 batch no: 20116053 the incident occurred approximately at 12:30 as the nurse was finishing the chemo.She said the ball did fall to the bottom of the drip chamber but then noticed the air in line.She filled the drip chamber up with saline to flush the remaining chemo through the line so i did not get a picture of the ball down in the drip chamber.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-06-21.H6: investigation summary one sample (model #11522558) and two photos were returned from the customer.It was reported that after a chemo infusion, air in line was noticed.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed successfully with saline.After priming, the set was drained to see where the ball would land.The ball landed where it should at the bottom of the drip chamber and did not allow air in the line.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review for model 11522558 lot number 20116053 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17nov2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported that the as lvp 20d 3ss cv bv experienced air bubbles/air in line.The following information was provided by the initial reporter: material no: 11522558, batch no: 20116053.The incident occurred approximately at 12:30 as the nurse was finishing the chemo.She said the ball did fall to the bottom of the drip chamber but then noticed the air in line.She filled the drip chamber up with saline to flush the remaining chemo through the line so i did not get a picture of the ball down in the drip chamber.

• Brand Name: AS LVP 20D 3SS CV BV
• 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: 11971704
• MDR Text Key: 260626483
• Report Number: 9616066-2021-51300
• Device Sequence Number: 1
• Product Code: FPA
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/14/2023
• Device Catalogue Number: 11522558
• Device Lot Number: 20116053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1