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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris pump infusion set had leakage.The following information was provided by the initial reporter: when removing epi tubing from the pump i noticed the tubing was wet and the tubing was squirting epi out of the tubing.Quantity affected: (b)(4) ea was there injury? no.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
One sample was submitted for quality evaluation.Visual inspection of the sample did not indicate any damages or abnormalities.The infusion set was then primed and a leak was identified on the silicone tubing at the upper pumping segment fitting.Under magnification a hole was identified on the sample.The customer complaint of leakage was confirmed.Based on the examination of the sample and details of the leakage described by the customer, it was determined that the root cause of the issue was a probable misloading of the infusion set.The leakage was only identified when the tubing was in the pump and not during priming, and therefore the tubing may have been damaged during loading of the infusion set.The bd clinical team has been made aware of the issue and they will be in contact with the customer to determine if further training or instruction is needed for proper use of the infusion sets.A device history record review could not be performed because the lot number is unknown.

• Brand Name: BD ALARIS PUMP INFUSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23587119
• Report Number: 9616066-2025-03503
• Device Sequence Number: 18491243
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/10/2025
• 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