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

Model Number 2426-0500

Device Problem Leak/Splash (1354)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

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 the tubing of the bd alaris¿ pump module smartsite¿ infusion set was found disconnected from the pump when removing it from the packaging.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "the first tubing ref 2426-0500, lot #(10)21073311 our emergency department (ed) reports that they took the tubing out of the package and it was disconnected below the pump segment just below the y-site.".

Event Description

It was reported that the tubing of the bd alaris¿ pump module smartsite¿ infusion set was found disconnected from the pump when removing it from the packaging.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "the first tubing ref (b)(4), lot #(10)21073311 our emergency department (ed) reports that they took the tubing out of the package and it was disconnected below the pump segment just below the y-site.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 11/3/2021 h.6.Investigation: a complaint of tubing being separated out of packaging was received from the customer.A sample and photo were provided for investigation.In the photo, the set is seen to be separated below the second y-site.The customer complaint was confirmed.Through visual inspection of the physical sample, some solvent could be seen, but it did not go all the way around the connection site.A device history record review for model 2426-0500 lot number 21073311 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The possible root causes for this defect include, lack of fixtures to ensure holding time, not giving enough holding time during assembly, the solvent dispenser not working properly and the bonding procedure not being performed correctly.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of leakage with lot #21073311 regarding item #2426-0500.H3 other text : see h.10.

• 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: 12710054
• MDR Text Key: 278807988
• Report Number: 9616066-2021-52319
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: 37613203021006
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 21073311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• 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