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

Catalog Number	10062818
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2025
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 blood infusion set back flowed.The following information was provided by the initial reporter: i noticed that my blood in the tubing looked super diluted.I traced it up to the bag and the bag looked overfilled and diluted but if you trace the tubing closer to the patient it didn't look diluted.I made sure to check my clamp on my ns side and the clamp was in place and didn't appear to have any issues.I finished what was left of the blood and put on my flush and a couple mins later i go back in because it is beeping air in line.Somehow my ns bag ran completely dry.So, while the blood was infusing, despite being clamped my ns was back priming into my blood bag.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual examination was conducted and no damages or abnormalities were identified.The set was then primed with water.A bag of water and blue dye was connected to one spike and a bag of clear water was connect to the other spike.A simulated infusion, at a rate of 125 ml/hr was then conducted with each of the infusion inlet lines clamped in order to keep the two liquids from back flowing into the other bag.There were no signs of leakage, air-in-line, occlusion or backflow.The customer complaint of backflow could not be verified.A root cause for the failure could not be determined because the failure could not be replicated.A device history record review for model 10062818 lot number 23125284 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 BLOOD 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: 21970328
• Report Number: 9616066-2025-01136
• Device Sequence Number: 20873152
• Product Code: FPA
• UDI-Device Identifier: 07613203019668
• UDI-Public: (01)07613203019668(11)231213(17)261213(10)23125284
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: 10062818
• Device Lot Number: 23125284
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown