MAUDE Adverse Event Report: GEM V/NV 20DP LOW SORBING NO PORTS; INTRAVASCULAR ADMINISTRATION SET

Model Number	11426964
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one photo of primary set, model 11426964, was received by the customer for investigation.Upon visual inspection, it could be observed that the tubing was attached to a phaseal optima injector and evidence of leakage could be seen.No other defects were observed in the photo provided.The customer's complaint that the alaris tubing set was leaking a chemo drug was verified.However, without a physical sample returned, an investigation could not be performed and a root cause could not be determined.A device history record review could not be performed on model 11426964 because a lot number was not provided by the customer.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: without a physical sample returned, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that the gem v/nv 20dp low sorbing no ports experienced leakage at connection.The following information was provided by the initial reporter: nurse noticed drug on the floor and dripping from the tubing (alaris #11426964) towards the end of the infusion.Chemo was administered at approx 500 ml/ hr with an alaris pump.Customer felt that the leak occurred between the spin collar connection and the phaseal optima injector (product 515057), which had been attached in pharmacy.All pharmacy staff has been trained and retrained in how to connect these components.

• Brand Name: GEM V/NV 20DP LOW SORBING NO PORTS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12375567
• Report Number: 9616066-2021-51901
• Device Sequence Number: 17160641
• Product Code: FPA
• UDI-Device Identifier: 50885403232365
• UDI-Public: 50885403232365
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/01/2021

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: 11426964
• Device Catalogue Number: 11426964
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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