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

Catalog Number	11522558
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion set was damaged the following information was received by the initial reporter with the verbatim; on previous site visits, cpc determined that the practice in the infusion center of over programming the vtbi (volume to be infused) to include the flush was a contributing factor to the failure of the ball seating properly.A vacuum is created which can potentially prevent the ball from completely sealing the valve.If there is a deformity in the drip chamber this can also lead to the ball not seating properly.
Additional Manufacturer Narrative
H:3.If a device evaluation and/or device history review is completed, 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: 18423491
• Report Number: 9616066-2023-02454
• Device Sequence Number: 20766173
• Product Code: FPA
• UDI-Device Identifier: 50885403232303
• UDI-Public: (01)50885403232303
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (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): 12/14/2023

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: 11522558
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown