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

Catalog Number	10015012
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the tubing had a large bubble near the filter, and when the tubing was disconnected, the tpn backflowed.One sample of material 10015012, lot number unknown, was returned.Upon initial visual examination, the set had no defects or abnormalities.The set was set to run tapwater at 125 ml/hr for 1 hour, in order to test the air inline and backflow issue.The issue was unable to be replicated.After priming, the set ran without issue.The complaint of air in line could not be verified.The root cause for the issue is unknown without a replicated failure.There are possible root causes related to the tpn and filter relationship, however that should not arise after just 2 hours of infusion, the only potential issues are with day long infusions.The supplier of the filter has been notified of the failure.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
It was reported that bd alaris pump module smartsite burette infusion set had air in line the following information was received by the initial reporter with the following verbatim.Tpn line air alarm with large volume past pump x2 within 2 hours of fixing air alarms.Rn noted a large bubble near filter and elected to disconnect and prime line to remove.Once disconnected and unclamped fluid went in opposite direction, against gravity and natural movement back into buretrol - causing tubing to be full of air at the bottom of the line and fluid would not move down despite positioning attempts to assist gravity.Rn replaced tubing with set from new bag of sets in cardiac supply room.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE BURETTE 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: 21649441
• Report Number: 9616066-2025-00589
• Device Sequence Number: 9276403
• Product Code: FPA
• UDI-Device Identifier: 10885403233951
• UDI-Public: (01)10885403233951
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• 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): 02/27/2025

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: 10015012
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown