MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20D 0.2 FLTR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2232-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one used primary set, model 2232-0007, was received by the customer for investigation.Upon visual inspection, a piece of tape was applied to the silicon segment of the tubing.No defects were visually observed.The tape was removed and the sample was primed with a blue dye solution and a leak could clearly be seen.A device history record review could not be performed on model 2232-0007 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 upper fitment.The customer's complaint of a small hole/slit in the tubing was verified.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: 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.
Event or Problem Description
It was reported that gem v/nv 20d 0.2 fltr tubing ruptured.The following information was provided by the initial reporter: material #: 2232-0007 batch/lot #: unknown it was reported that there is a small hole/slit in the tubing.Verbatim: iv tubing primed with fluids and hooked up to patient.Nurse noticed a puddle on the floor under iv pump.Iv pump was dripping fluid out of iv pump channel.Nurse changed iv tubing and noticed that there is a small hole/slit in the tubing.Iv tubing saved for reference.

• Brand Name: GEM V/NV 20D 0.2 FLTR
• 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: 11697846
• Report Number: 9616066-2021-50770
• Device Sequence Number: 19615149
• Product Code: FPA
• UDI-Device Identifier: 10885403463969
• UDI-Public: 10885403463969
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/09/2021

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 Catalogue Number: 2232-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1