MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM 10DP CKV 3SS 2G 4WAY STCK; INTRAVASCULAR ADMINISTRATION SET

Model Number	10015896
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one used primary set, model 10015896, was received by the customer for investigation.The set was visually inspected and no defects were observed.The sample was primed with a blue dye solution and a leak could clearly be seen coming from the base of the silicon pumping segment.The customer's complaint that the tubing was leaking from the blue piece that plugs into the pump was verified.A device history record review could not be performed on model 10015896 because a lot number was not provided by the customer.Visual inspection under magnification was performed on the tubing and a tear was observed in the silicon pumping segment where it connects with the lower fitment.The root cause of the tear cannot be determined.However, we encourage the customer to load the pumping segment top first before the bottom, as doing the opposite is a known cause of this failure.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
It was reported that the gem 10dp ckv 3ss 2g 4way stck experienced leakage.The following information was provided by the initial reporter: material #:10015896.Batch/ lot #: unknown.When arriving to med surge 3.The med surg rn noticed that the iv tubing was wet.The tubing was removed from the patient and the line was capped.The tubing was leaking from the blue piece that plugs into the pump.

• Brand Name: GEM 10DP CKV 3SS 2G 4WAY STCK
• 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: 12051908
• Report Number: 9616066-2021-51361
• Device Sequence Number: 14318988
• Product Code: FPA
• UDI-Device Identifier: 50885403234062
• UDI-Public: 50885403234062
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 05/27/2021

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 Model Number: 10015896
• Device Catalogue Number: 10015896
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1