MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 6-IN STANDARDBORE TRI-FUSE SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME1224
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.The customer complaint of fluid leaking from the area where the 3 ports connect to one could not be verified due to the product not being returned for failure investigation.A device history record review for model me1224 lot number 17116882 was performed.The search showed that a total of 4,803 units in 1 lot number was built on 11nov2017.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: due to no sample received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that the 6-in standardbore tri-fuse set experienced leakage.The following information was provided by the initial reporter: we've had a consistent amount of issues with fluid leaking from the area where the 3 ports connect to one.Medication is placed into this connection during heart surgery and is leaking onto a towel instead of making it into the patient.

• Brand Name: 6-IN STANDARDBORE TRI-FUSE 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
• MDR Report Key: 12220908
• Report Number: 9616066-2021-51620
• Device Sequence Number: 4136970
• Product Code: FPA
• UDI-Device Identifier: 50885403236110
• UDI-Public: 50885403236110
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 06/29/2021

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: 11/11/2022
• Device Model Number: ME1224
• Device Catalogue Number: ME1224
• Device Lot Number: 17116882
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1