MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. EXT SET 1.2MF 1SS DEHP FREE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20127E
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
One set model 20127e was returned for investigation.The set was examined for defects and abnormalities.The filter vents appeared to be wetted out.No other defects or abnormalities were observed.The set was primed with water and a leak was confirmed at the filter inlet port.The set was laid out to dry the filter vents.Additional air under water test was performed.The set was pressurized with about 10psi and the vent was submerged under water.There was a steady stream of air bubbles coming from the filter vents and the hydrophobicity of the membrane was restored.The likely cause of the leakage and the hydrophobicity of the membrane being compromised is the drug being used in the set compromising the membrane.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.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It is reported air in line.Description: bd filter connected to 30 ml syringe.Filter primed well with tpn.Upon going to connect to patient, filter found to have air.Primed again with syringe and then clamped.Unclamped and again filled with air.Tried priming on pump and pump kept saying "prime stopped".Hand primed tubing and still kept filling with air.Ended up changing filter to smaller bd filter- no issues noted with changing to small filter.Have had similar incidents before with large filter connected to syringe- unsure if a new process change needs implemented to instead use the smaller filters when using them with syringes.

• Brand Name: EXT SET 1.2MF 1SS DEHP FREE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24241161
• Report Number: 9616066-2026-00201
• Device Sequence Number: 10188337
• Product Code: FPA
• UDI-Device Identifier: 07613203019248
• UDI-Public: (01)07613203019248(17)270612(10)24069281
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 03/25/2026

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: Health Professional
• Device Catalogue Number: 20127E
• Device Lot Number: 24069281
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown