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

Catalog Number	10942011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris pump infusion set was damaged.The following information was provided by the initial reporter: regular large bore iv tubing was beeping air in line.I pulled the tubing out of the pump to remove the air bubbles, and when i attempted to flick the tubing, a small hole was seen that squirted fluids.Tubing was removed and replaced with undamaged tube.
Additional Manufacturer Narrative
It was reported by customer that iv tubing was beeping air in line.They pulled the tubing out of the pump to remove the air bubbles, and when they attempted to flick the tubing, a small hole was seen that squirted fluids.Tubing was removed and replaced with undamaged tube.One sample was received for quality evaluation.Visual inspection of the sample did not indicate an obvious damages.When the infusion set was primed, leakage was noticed on the silicone tubing at the lower pumping segment.Additionally, since there was a leak at that location, air was allowed to enter into the infusion set.The customer complaint of tubing defective/damaged was confirmed, however, the reported air-in-line was not verified.The issue was reported to manufacturing and it was determined that the root cause is most likely a misloading of the infusion set into the alaris pump.Since the issue of air-in-line and leakage were not identified until after the set was loaded into the pump, the issues were mostly created by misloading the infusion set into the pump, causing for liquid to leak out of the tubing and appearing that air is in the infusion line.The bd clinical team has been made aware and will be in contact if further instructional material or training is needed for the proper use of the product.The reported lot number for the sample was reported as unknown.Device history review was could not be conducted.

• Brand Name: BD ALARIS PUMP 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: 22612656
• Report Number: 9616066-2025-02132
• Device Sequence Number: 14807234
• Product Code: FPA
• UDI-Device Identifier: 10885403232404
• UDI-Public: (01)10885403232404
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K221327
• Number of Events Summarized: 1
• Summary Report (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): 09/26/2025

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: 10942011
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/29/2025
• 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