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

Catalog Number	24301-0007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
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 bd alaris pump module smartsite texium low sorbing infusion set was leaking the following information was received by the initial reporter with the following verbatim.It was reported by customer that two instances of chemotherapy tubing that had a possible leak around the 0.2 micron filter.The leak was described as a small amount of fluid on the outside of the filter, which his not near the connection site to the patient iv or the medication bag.Since this happened twice in 24 hours, we are wondering if there might be an issue with the lot that we have.
Event or Problem Description
Material#: 24301-0007t.Batch number#: 24075212/ 24045383.It was reported by customer that two instances of chemotherapy tubing that had a possible leak around the 0.2 micron filter.The leak was described as a small amount of fluid on the outside of the filter, which his not near the connection site to the patient iv or the medication bag.Since this happened twice in 24 hours, we are wondering if there might be an issue with the lot that we have.Verbatim#: two instances of chemotherapy tubing that had a possible leak around the 0.2 micron filter.The leak was described as a small amount of fluid on the outside of the filter, which his not near the connection site to the patient iv or the medication bag.Since this happened twice in 24 hours, we are wondering if there might be an issue with the lot that we have.
Additional Manufacturer Narrative
The customer reported filter leaks when administering chemo and returned a photo of the incident.The sample is of material 24301-0007t and is one of lots 24075212 or 24045383.The photo was examined and the leak from filter air vents was verified.Without the physical sample, the investigation cannot be confirmed.There is a possible root cause for filter leakage when administering low surface tension fluids like alcohol and lipids, as these may weaken or compromise the hydrophobic properties of the air vent.Although the issue was unable to be replicated, and the root cause is unknown bd is looking at opportunities to improve the filter function to alleviate this failure in the future.A device history record review 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 TEXIUM LOW SORBING 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: 21143827
• Report Number: 9616066-2024-02258
• Device Sequence Number: 9645732
• Product Code: FPA
• UDI-Device Identifier: 10885403223198
• UDI-Public: (01)10885403223198
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: 24301-0007T
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/24/2025
• 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