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

Model Number	11522558
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing broke off below the cassette after infusing remicade and leaked.This complaint was created to capture the 2nd of 4 related incidents.The following information was provided by the initial reporter: "bd alaris ball valve pump infusion set was used for medication infusion (remicade).At the end of the infusion when attempting to remove the tubing from the pump for disposal, the tubing broke off below cassette.There have been four events in the past week where the tubing becomes disconnected from the cassette.In two cases the medication leaked through and had to be reordered and a second dose prepared by pharmacy.".
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of four events of separation were received from the customer.Pictures of the lot and the sample were returned for investigation.In the photo, the tubing is seen to be separated at the lower part of the pumping segment, after the safety clamp.The customer complaint of separation was confirmed.A device history review was completed for the known lot.A device history record review for model 11522558 lot number 22095036 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.After investigation, it was determined by the manufacturing plant that the most potential root cause that generates the separation of the tubing and lower fitment is the omission of solvent application by operator.In addition, although the process has an inspection step for 100% of the product, there were found opportunities in the method of inspection.A trend for this separation issue has been identified for this product line.A capa (corrective action preventative action) has been initiated, and a team has been assembled in order to investigate the issue.
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing broke off below the cassette after infusing remicade and leaked.This complaint was created to capture the 2nd of 4 related incidents.The following information was provided by the initial reporter: "bd alaris ball valve pump infusion set was used for medication infusion (remicade).At the end of the infusion when attempting to remove the tubing from the pump for disposal, the tubing broke off below cassette.There have been four events in the past week where the tubing becomes disconnected from the cassette.In two cases the medication leaked through and had to be reordered and a second dose prepared by pharmacy.".

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET
• Common Device Name: 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: 16280709
• Report Number: 9616066-2023-00122
• Device Sequence Number: 6522736
• Product Code: FPA
• UDI-Device Identifier: 50885403232303
• UDI-Public: 50885403232303
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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
• Operator of Device: Other
• Device Expiration Date: 09/01/2025
• Device Model Number: 11522558
• Device Catalogue Number: 11522558
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown