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	Anemia (1706)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that gem v/nv 20d 0.2 fltr tubing broke off from filter and leaked.The following information was provided by the initial reporter: material no.: 2232-0007 batch no.: unknown.It was reported the tubing broke off from the filter.(b)(6) month old patient broke iv tubing at micron filter extension which led to blood flowing out of broken line from central line in half hour between 0800 rounding and nurse checking in at 0830.As a result of this blood loss patient required a clave change on line and dressing change, neither of which would have been required for several days.This significantly increased patient's infection risk during count.Patient also required a cbc to be drawn which showed a noteworthy drop in hemoglobin and hematocrit, nearly causing patient to require blood transfusion.
Additional Manufacturer Narrative
H6: investigation summary: a sample was received and tested by our quality team.The separation was immediately noticed and the customer's complaint has been verified.Microscope analyses was employed to determine the root cause of this failure and with an appropriate amount of solvent on the tubing portion, the failure is due to a shallow insertion at the tubing junction.A device history record review could not be performed 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.H3 other text : see h10.
Event or Problem Description
It was reported that gem v/nv 20d 0.2 fltr tubing broke off from filter and leaked.The following information was provided by the initial reporter: material no.: 2232-0007.Batch no.: unknown.It was reported the tubing broke off from the filter.15 month old patient broke iv tubing at micron filter extension which led to blood flowing out of broken line from central line in half hour between 0800 rounding and nurse checking in at 0830.As a result of this blood loss patient required a clave change on line and dressing change, neither of which would have been required for several days.This significantly increased patient's infection risk during count.Patient also required a cbc to be drawn which showed a noteworthy drop in hemoglobin and hematocrit, nearly causing patient to require blood transfusion.

• 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: 11829352
• Report Number: 9616066-2021-51022
• Device Sequence Number: 16937068
• 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,Followup
• Report Date (Section B): 06/28/2021

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: 04/23/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 MO