MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP BUR 60D 2SS BV; INTRAVASCULAR ADMINISTRATION SET

Model Number	2447-0007
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ lvp bur 60d 2ss bv was damaged and leaked.The following information was provided by the initial reporter: sterile tubing change was completed for uvc infusing tpn @ 1700.@ 1745 the pump was alarming air in line.When i was removing air from the line it was noted to be slightly wet.Upon further inspection, there was a tiny hole in the tubing leaking tpn.
Additional Manufacturer Narrative
Investigation summary: a complaint of a tiny hole in the tubing causing leakage was received from the customer.A sample was returned for investigation.Through visual inspection, no defects or damages were observed on the set.The set was then attempted to be primed with water, but fluid could not pass through the first y-site.A syringe was attached to the y-site to pull the fluid through but it was not possible.The syringe was then used to push water through the y-site and it was able to flow through, but with some bubbles in the tubing.The set was then infused, but an occlusion alarm popped up on the pump.The set was attempted to be primed two more times but the pumped alarmed with an air-in-line issue.A leakage test was performed to locate the hole and it was found at the top of the pumping segment.A device history record review for model 2447-0007 lot number 20125219 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09dec2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect.The root cause was determined to be misloading of the pump.These small holes on the pumping segment are created when the tubing is loaded from bottom to top.The segment should be loaded from the top to bottom to prevent these tears.This incident has been added to our database of reported incidents.

• Brand Name: BD ALARIS¿ LVP BUR 60D 2SS BV
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14955878
• Report Number: 9616066-2022-00833
• Device Sequence Number: 6906133
• Product Code: FPA
• UDI-Device Identifier: 50885403235076
• UDI-Public: 50885403235076
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

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 Expiration Date: 12/09/2023
• Device Model Number: 2447-0007
• Device Catalogue Number: 2447-0007
• Device Lot Number: 20125219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown