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

Catalog Number	20129E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.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 extension set was leaking the following information was received by the initial reporter with the following verbatim: customer noted: while performing cares, noted infant's swaddle was slightly damp.Traced lines and felt moisture on lipid filter.Replaced filtered and changed out swaddle blanket.
Event or Problem Description
Material # 20129e lot # unknown, it was reported by customer that they noted infant's swaddle was slightly damp.Traced lines and felt moisture on lipid filter.Verbatim: rcc received a complaint via email.Product 20129e lot h37020129e1b bd extension set smallbore tubing 1.2 micron low protein binding filter.Customer noted: while performing cares, noted infant's swaddle was slightly damp.Traced lines and felt moisture on lipid filter.Replaced filtered and changed out swaddle blanket.This was a problem with the same tubing different lot number in november 2023.Regards.
Additional Manufacturer Narrative
The customer reported that the lipid filter was leaking, and returned two used sets of material 20129e.Upon initial visual examination, the sets had no defects or abnormalities.The sets were infused with water, but no leak was observed, and the complaint was not verified.Based on previous failures, the filter leak can be caused by the air vent membrane losing its hydrophobicity.The potential root cause for this is the drugs/solutions used have low surface tensions, below 30 dynes p/cm.This affects the hydrophobicity and causes the filter to wet out.The root cause is potentially related to the user drugs/solutions.

• Brand Name: BD ALARIS EXTENSION 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: 19402557
• Report Number: 9616066-2024-00798
• Device Sequence Number: 20527370
• Product Code: FPA
• UDI-Device Identifier: 10885403234903
• UDI-Public: (01)10885403234903
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 12/16/2024

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: 20129E
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 12/19/2024
• 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