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
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set disconnected from the line.The following information was provided by the initial reporter: clinical products advisor of the hospital reported that one of the oncology 5 port lines, the smartsite connector disconnected from the line.
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set disconnected from the line.The following information was provided by the initial reporter: clinical products advisor of the hospital reported that one of the oncology 5 port lines, the smartsite connector disconnected from the line.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 22035395.D4: medical device expiration date: 03-mar-2025.H4: device manufacture date: 03-mar-2022.D10: device available for eval yes.D10: returned to manufacturer on: 10-may-2023.H6: investigation summary one 11426965 sample was received without the packaging for investigation furthermore, the lot number of the complaint sample was reported unknown.Residual fluid was detected in the device.A visual inspection of the returned sample confirmed the customer's experience, as the tubing joint of the lower smartsite y-site had separated.A close inspection of the location of separation suggests minimal signs of solvent were present at the affected joint.The details of this feedback were forwarded to the manufacturing site for investigation.Following a review of the manufacturing process, their analysis confirmed that the separation is most likely to have been caused by an insufficient amount of solvent having been applied to the tubing during the assembly process.This is a manually performed assembly step and is likely to have occurred due to human error.Evaluation of the laser inscribed smartsite® id determined the likely lot number for the affected product to be 22035395.A review of the production records for lot 22035395 did not identify any in-process testing failures or quality deviations which may have resulted in a fault of this nature.

• 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 ; 8448235433
• MDR Report Key: 16691482
• Report Number: 9616066-2023-00642
• Device Sequence Number: 6080251
• Product Code: FPA
• UDI-Device Identifier: 10885403232558
• UDI-Public: 10885403232558
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: 03/03/2025
• Device Catalogue Number: 11426965
• Device Lot Number: 22035395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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