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

Catalog Number	10010453
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 bd alaris pump module smartsite low sorbing infusion set the following information was received by the initial reporter with the verbatim: ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): on (b((6) 2023.Site name/location: (b)(6) hospital.Level of harm: no apparent harm - reached patient/person, inconvenient.Ahs optional report to cmdsnet (health canada): incident details: smof lipids held for administration of pip-taz antibiotic.Paused on alaris pump.After first dose was given with no issues, after second dose of antibiotic in day shift, approximately 20minutes after re-starting smof, pump rang off occluded patient side.Upon trouble-shooting line, alaris tubing of smof, no longer able to run any volume through or pull any volume through past filter portion closest to patient.Tubing had to be changed.Impact of incident: no evident concern.Who was affected? patient.

• Brand Name: ALARIS PUMP MODULE SMARTSITE LOW SORBING 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: 18117213
• Report Number: 9616066-2023-02183
• Device Sequence Number: 7503299
• Product Code: FPA
• UDI-Device Identifier: 37613203021143
• UDI-Public: (01)37613203021143
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2023

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: 10010453
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/11/2023
• 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