MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ PUMP MODULE ADMINISTRATION SETS; INTRAVASCULAR ADMINISTRATION SET

Model Number 10010453

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

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown investigation summary: one used sample was returned for investigation.Prior to functional testing the set was visually examined for defects and abnormalities.Kinks were found in the tubing set and massaged out.No other defects or abnormalities were observed.Set was attached to an iv bag filled with 85% glycerin/ 15% water solution and allowed to prime using gravity.The sample was able to be primed and flowed with gravity.The customer complaint that the fluid would not flow through the tubing could not be replicated.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported bd alaris¿ pump module administration sets was clogged, blocked, or occluded.The following information was provided by the initial reporter: ".Pump for lipids began to alarm ¿occlusion patient side¿ but tpn side was not alarming.Port where tpn and lipids was infusing was flushing without resistance.Lipids tubing checked for kinks and clamps but no kinks or clamps on.Lipid tubing disconnected from picc and let to free flow but no fluid was flowing from tubing.".

• Brand Name: BD ALARIS¿ PUMP MODULE ADMINISTRATION SETS
• 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: 12652559
• MDR Text Key: 277134688
• Report Number: 9616066-2021-52251
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021143
• UDI-Public: 37613203021143
• 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
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10010453
• Device Catalogue Number: 10010453
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Date Manufacturer Received: 09/20/2021
• 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