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

Model Number 2434-0007

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/20/2021

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.Medical device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that bd alaris¿ pump module smartsite¿ infusion set leaked."it was reported by the customer that the tubing was leaking due to a small fracture at the y site.".

Manufacturer Narrative

H.6.Investigation: a complaint of leakage due to a fracture on the y-site was received from the customer.No product or photo was returned by the customer.The customer complaint of component damage 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 2434-0007 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported that bd alaris¿ pump module smartsite¿ infusion set leaked."it was reported by the customer that the tubing was leaking due to a small fracture at the y site.".

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12839482
• MDR Text Key: 281865189
• Report Number: 9616066-2021-52451
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203019690
• UDI-Public: 37613203019690
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• 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,Followup
• Report Date: 03/23/2022

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 Model Number: 2434-0007
• Device Catalogue Number: 2434-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 04/04/2022
• 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