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

Catalog Number	10015896
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion set was leaking.The following information was received by the initial reporter with the verbatim: customer stats i also wanted to pass along that we entered approximately 4-5 midas for the ref# 10015896, after connecting the tubing we found multiple leaks throughout the tubing hub areas.Not sure if you heard this from anyone else? should the follow up communication be sent to you? yes please.Were any of the sets saved to send in for evaluation? not at this time, if we have another issue, i will make sure to pass along to the team to save the tubing.In meantime, we have instructed the team to tighten each hub area before delivering medication/fluids.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18041481
• Report Number: 9616066-2023-02136
• Device Sequence Number: 12797825
• Product Code: FPA
• UDI-Device Identifier: 10885403234064
• UDI-Public: (01)10885403234064
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

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 Catalogue Number: 10015896
• 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: 10/10/2023
• Initial Report FDA Received Date: 10/31/2023
• 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