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

Catalog Number	42081E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
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 bd alaris smartsite gravity blood set was leaking.The following information was received by the initial reporter with the following verbatim."from rn: blood tubing primed with normal saline bag.After spiking blood product and opening roller clamp i noticed blood leaking from bifurcation above the filter.I reclamped the blood portion and replaced the tubing with gravity hand pump tubing without incident.~10-20 cc of blood was lost to floor and defective tubing.".
Additional Manufacturer Narrative
It was reported that there was a leak above the filter.One sample model 42081e was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water and a leak was observed coming from one of the tubing ports above the filter.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the potential root cause of leak between tubing and blood drip chamber could be related to an incorrect solvent application by the assembler.The sku reported on this complaint will be manufactured at a different location.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.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS SMARTSITE GRAVITY BLOOD 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: 21324787
• Report Number: 9616066-2025-00149
• Device Sequence Number: 12935909
• Product Code: FPA
• UDI-Device Identifier: 07613203020855
• UDI-Public: (01)07613203020855
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• 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): 03/17/2025

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: 42081E
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/19/2025
• 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