MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 10015012

Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)

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

Event Date 02/14/2021

Event Type  malfunction  

Manufacturer Narrative

Fda notified: the initial reporter also notified the fda on (date) via medwatch # (b)(4).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 alaris pump module smartsite burette infusion set experienced a case of leakage, and a case of air bubbles/air in line.The following information was provided by the initial reporter: material no.: 10015012.Batch no.: unknown.Pump reading "air in line" tpn leaking.

Manufacturer Narrative

Investigation summary: no product or photo was returned by the customer.The customer complaint of air in line 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 10015012 because a valid lot number was not provided by the customer.The root cause of this failure could not be identified without a failure investigation.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 that alaris pump module smartsite burette infusion set experienced a case of leakage, and a case of air bubbles/air in line.The following information was provided by the initial reporter: material no.: 10015012, batch no.: unknown.Pump reading "air in line" tpn leaking.

• Brand Name: ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION 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: 12081175
• MDR Text Key: 263535516
• Report Number: 9616066-2021-51408
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403233959
• UDI-Public: 50885403233959
• 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: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10015012
• Device Catalogue Number: 10015012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1