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

Catalog Number 47177E

Device Problem Gas/Air Leak (2946)

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

It was reported that the gravity administration set experienced air in line.The following information was provided by the initial reporter: airlocked.

Manufacturer Narrative

Investigation summary - a complaint of set being air locked was received from the customer.Five unopened samples were returned for investigation.Through visual inspection, no defects or damages were observed.The set was primed and an infusion was completed with no issues or alarms from the infusion pump.The defect could not be replicated.A device history record review for model 47177e lot number 22079054 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause could not be determined due to the defect not being able to be replicated.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: GRAVITY ADMINISTRATION 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16534800
• MDR Text Key: 311580540
• Report Number: 9616066-2023-00437
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235436
• UDI-Public: 10885403235436
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820278
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 47177E
• Device Lot Number: 22079054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2022
• 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