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	Leak/Splash (1354)
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
Medical device expiration date: unknown.Device manufacture date: unknown.Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris pump module smartsite infusion set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: the iv infusion set was leaking from the lowest port (closest to the patient); patient called rn and reported that her iv was "leaking" when arriving to the room, the bed sheets and part of the patients clothes were visible wet.No leaking was noted around the port site.Connections were checked and were tight.Patient had two tubings connected via y site.Tubing running normal saline was assessed and it was noted that the lowest port (closest to the patient) of the 5 port tubing was leaking saline.A 10 ml ns syringe was connected to the highest port and when it was pushed, saline would shoot out of the lowest port.Only saline was running through the line at the time.
Event or Problem Description
It was reported while using bd alaris pump module smartsite infusion set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: the iv infusion set was leaking from the lowest port (closest to the patient); patient called rn and reported that her iv was "leaking" when arriving to the room, the bed sheets and part of the patients clothes were visible wet.No leaking was noted around the port site.Connections were checked and were tight.Patient had two tubings connected via y site.Tubing running normal saline was assessed and it was noted that the lowest port (closest to the patient) of the 5 port tubing was leaking saline.A 10 ml ns syringe was connected to the highest port and when it was pushed, saline would shoot out of the lowest port.Only saline was running through the line at the time.
Additional Manufacturer Narrative
H6: investigation summary the customer complaint of leaking from the lowest port was verified from the provided picture.The root cause could not be determined without a physical sample.A device history record review could not be performed on material 11426965 because the lot number is unknown.

• 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: 16251442
• Report Number: 9616066-2023-00095
• Device Sequence Number: 5351038
• Product Code: FPA
• UDI-Device Identifier: 10885403232558
• UDI-Public: (01)10885403232558
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/15/2023

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: Health Professional
• Device Catalogue Number: 11426965
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/06/2023
• 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