MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. V/NV BURETTE SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 82113E-0006

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 05/01/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that v/nv burette set had air in the line.This occurred on 3 occasions.The following information was provided by the initial reporter: patient with hickmans cvl receiving blood products.Iv line getting air in line, so cvl having to be accessed to get out air.This happened 3 times - iv lines changed but problem continued so burette changed and blood able to be infused without further problems.

Manufacturer Narrative

H6: investigation summary : two 82113e-0006 samples were received without packaging for investigation; both samples were received connected to a dual infusion set manufactured by fresenius kabi.One of the infusion sets was received spiked into a 100ml bag of nacl; all products were received filled with residual fluid.A visual inspection of the returned samples did not identify any obvious manufacturing defects which may have contributed to the customer's experience.The samples were then subjected to functional testing by spiking each burette into an iv container from bd stock and subjecting to a gravity infusion; no air ingress or leakage was observed throughout testing.Each of the burettes were then subjected to pressure testing in order to observe for any leakage; again no leakage or air ingress was observed throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21016457 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the customer¿s experience in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 82113e-0006 product in the past 12 months.

Event Description

It was reported that v/nv burette set had air in the line.This occurred on 3 occasions.The following information was provided by the initial reporter: patient with hickmans cvl receiving blood products.Iv line getting air in line, so cvl having to be accessed to get out air.This happened 3 times - iv lines changed but problem continued so burette changed and blood able to be infused without further problems.

• Brand Name: V/NV BURETTE SET
• 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: 11936641
• MDR Text Key: 257603408
• Report Number: 9616066-2021-51250
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/26/2024
• Device Catalogue Number: 82113E-0006
• Device Lot Number: 21016457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2021
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1