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

Model Number 2455-0500

Device Problem Contamination (1120)

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

Event Date 01/03/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: address information was not able to be obtained, therefore, nj was used as a place holder.Device evaluated by mfr: 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 while using bd alaris pump module smartsite infusion set foreign matter discolored the drip chamber.There was no report of patient impact.The following information was provided by the initial reporter: the dark drip chamber and the slight darkness of the tubing itself is something new.

Event Description

It was reported while using bd alaris pump module smartsite infusion set foreign matter discolored the drip chamber.There was no report of patient impact.The following information was provided by the initial reporter: the dark drip chamber and the slight darkness of the tubing itself is something new.

Manufacturer Narrative

H6: investigation summary a complaint of drip chamber being a brown color was received from the customer.No product or photo was returned by the customer.The customer complaint of cosmetic issues - discoloration could not be verified due to the product not being returned for failure investigation.A device history record review for model 2455-0500 lot number 20086933 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16229977
• MDR Text Key: 308651597
• Report Number: 9616066-2023-00045
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021303
• UDI-Public: (01)37613203021303
• 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: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/19/2023
• Device Model Number: 2455-0500
• Device Catalogue Number: 2455-0500
• Device Lot Number: 20086933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1