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

Catalog Number	2232-0007
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris set had air in line.The following information was received by the initial reporter with the following verbatim: it was reported by customer that iv pump kept beeping air in line for tubing that had no air.Rn tried multiple times to reset tubing, switched pumps still air in line message occurred.Rn had to change out all the iv tubing for it to work.
Additional Manufacturer Narrative
It was reported that the pump kept alarming air in line when there was no air in the tubing.One sample model was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water an a short infusion was performed.No air in line alarm was observed.The customer complaint was unable to be replicated.Although the issue was unable to be replicated, a possible cause could have been improper loading of the tubing into the pump.A device history record review could not be performed because a lot number was not provided by the customer.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.

• Brand Name: BD ALARIS 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: 21354802
• Report Number: 9616066-2025-00196
• Device Sequence Number: 15693117
• Product Code: FPA
• UDI-Device Identifier: 10885403463969
• UDI-Public: (01)10885403463969
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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): 01/24/2025

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: 2232-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/11/2025
• 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