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

Catalog Number	10015862
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
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 module smartsite low sorbing infusion set had foreign matter in the fluid path.The following information was provided by the initial reporter: plastic spiral piece found in drip chamber.Additional information received from the customer: please confirm whether the plastic piece is found before the use or during the usage.The plastic was found once the fluid bag was spiked but before it was attached to the patient iv.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.None.
Additional Manufacturer Narrative
One sample received for quality evaluation.Visual inspection identifies a large piece of plastic within the drip chamber.The customer complaint of foreign matter was confirmed.The investigation was forwarded to the supplier group for further evaluation.The supplier investigation reviewed the production data of the possible batch numbers for the drip chambers produced at the same time as the submitted sample.There were no issues similar to the issue seen in the sample.A spectrum analysis was conducted on the foreign matter that was found in the drip chamber.The foreign matter was identified as a piece of pvc.It was determined that the pvc was the same as the pvc used to produce soft chamber of the sample.Based on this finding the possible root cause of the issue is that a piece of the pvc fell into the bags and into one of the chambers before being assembled.Considering the results of the statistical inspection ( more than 4000 pcs inspected and no similar defects) and defect rate ( less than 1.5 ppm) we can attribute this event to an isolated occasion that generated a number of parts within actual residual risk of the process.A device history record review for model 10015862 lot number 25065200 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24069052
• Report Number: 9616066-2025-04185
• Device Sequence Number: 16048774
• Product Code: FPA
• UDI-Device Identifier: 10885403221866
• UDI-Public: (01)10885403221866(17)280606(10)25065200
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 03/10/2026

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: 10015862
• Device Lot Number: 25065200
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown