MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD EXT SET 78; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MZ9329
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd ext set 78 tubing occluded.The following information was provided by the initial reporter: nicu had 3 cases of lipid tubing alarming on alaris pump after 5-10 hours of infusion, when changed out the problem stopped.We thought it was lot # 24029369, so i pulled all of that lot and the problem has stopped.I have 32 of these with this lot#.We would like to return to bd and get a different lot# replacement.I only have one of the tubings to give back, the other 2 were tossed.---------------------------- customer response received on 17-sep-2024 1.Could you please specify, what kind of alarming occurred? alaris pump alarming occulsion 2.Was there any defect or damage found in the tubing? unable to flush 3.Was there any leakage happened? no.
Additional Manufacturer Narrative
Investigation results: it was reported that there was an occlusion after 5-10 hours of infusion.One used sample and 32 unused samples were returned for investigation.The sets were examined for defects and abnormalities.Dried lipids were found inside the used tubing.No other defects or abnormalities were observed.The used set was flushed with water, the lipid blockage was removed and the set flowed normally.Since normal flow was established after flushing the lipids out of the filter, the probable cause of the blockage is the lipids clogging the filter and the filter working properly by blocking the larger lipid globules.The customer complaint was verified but no product defects were observed.A device history record review for model mz9329 lot number 24029369 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16feb2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD EXT SET 78
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 20412601
• Report Number: 9616066-2024-01459
• Device Sequence Number: 20864288
• Product Code: ONB
• UDI-Device Identifier: 10885403470127
• UDI-Public: (01)10885403470127(11)240216(17)270216(10)24029369
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: Health Professional
• Device Catalogue Number: MZ9329
• Device Lot Number: 24029369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown