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

Catalog Number 11426965

Device Problem Defective Device (2588)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris pump module smartsite infusion set was damaged the following information was received by the initial reporter with the following : primary 5-port iv tubing was inspected by rn when chemo was being connected to the primary line.Rn noticed crack in luer lock connector.Tubing was disconnected from patient.No packaging with lot # available.

Manufacturer Narrative

It was reported that the luer lock had broken off.Three samples model 11426965 with possible lots 23085362, 23085441, and unknown were returned for investigation.The sets were examined for defects and abnormalities.The tubing was not connected to a male luer.No other defects or abnormalities were observed.Upon visual inspection under the microscope the tubing showed no signs of solvent.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturing investigation, the most probable root cause of separation between tubing and male luer could be related to the incorrect solvent application by the assembler or due opportunities with the solvent dispenser.As a corrective action, the procedure was updated on november 09th, 2023 to improve cleaning and maintenance.A quality alert was created and communicated on april 02nd, 2023, to the involved personnel to reinforce the standard work instruction and the correct amount of solvent application.A dhr was done for model 11426965, possible lots 23085362, 23085441.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

No additional info.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18740771
• MDR Text Key: 335815818
• Report Number: 2016493-2024-15047
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232556
• UDI-Public: (01)50885403232556
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 11426965
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1