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 Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing broke below the blue and white cassette when removing it from the packaging.This complaint was created to capture the 4th of 4 related incidents.The following information was provided by the initial reporter: "a bd alaris pump infusion set ball valve back check valve was taken out of package during med infusion prep.Rn assessed the tubing and the connection broke below the blue and white cassette.".
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 below the blue and white cassette when removing it from the packaging.This complaint was created to capture the 4th of 4 related incidents.The following information was provided by the initial reporter: "a bd alaris pump infusion set ball valve back check valve was taken out of package during med infusion prep.Rn assessed the tubing and the connection broke below the blue and white cassette.".

• 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: 16280711
• Report Number: 9616066-2023-00123
• Device Sequence Number: 15083628
• 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: 22095036
• 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
• Date Device Manufactured: 08/29/2022
• 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