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

Catalog Number 2426-0500

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/26/2023

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 separated the following information was received by the initial reporter with the following verbatim: product description: bd alaris pump infusion set origin of the issue: product failure//design detail: the connector that is between the top y-site connector and the safety clamp in the pump segment of the tubing is coming apart, should be glued.

Manufacturer Narrative

Sample inv and dhr the customer reported separation and returned one used sample of material 2426-0500 and lot 23103166.The set was visually examined for defects and abnormalities.The separation in silicon segment at upper fitment of the pump segment was verified by visual inspection.Under a microscope, the ring retainer indent on the silicon was unable to be found.The ring retainer creates the binding for this connection, there is no solvent or glue.The manufacturing location found several root causes for the lack of ring retainer, including the retainer fixture for silicon tubing was dirty, incorrect set up, operator omits placing the ring, sensors did not detect missing ring.Actions taken by the plant are to improve the detection of the component by the sensors, and also to improve the cleaning process of the silicon.Device history record review for model 2426-0500 lot number 23103166 was performed.The search showed that a total of (b)(6) units in 1 lot number was built on 23oct2023.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.

Event Description

No additional information was provided.

• 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: 18587053
• MDR Text Key: 333843245
• Report Number: 9616066-2024-00074
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: (01)37613203021006
• 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: 02/28/2024

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: 2426-0500
• Device Lot Number: 23103166
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1