MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D DEHP 2SS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2410-0500
Medical Device Problem Codes	Complete Blockage (1094); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
It was reported that as lvp 20d dehp 2ss had a back flow issue.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.It was reported that there was a back flow issue where secondary medication was found in the primary medication bag.
Event or Problem Description
It was reported that as lvp 20d dehp 2ss had a back flow issue.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported that there was a back flow issue where secondary medication was found in the primary medication bag.
Additional Manufacturer Narrative
H.6.Investigation: 1 primary tubing and 1 secondary tubing were returned by the customer.It was reported that there was a back flow issue where secondary medication was found in the primary medication bag.The samples were examined for defects and abnormalities.No defects or abnormalities were observed.Functional testing was performed by using a primary bag filled with clear saline which was then used to prime the set.The secondary set was connected to a bag filled with a blue dye/water mixture, and then connected to the primary set.The sets were set up in a secondary infusion configuration with the fluid level of the secondary bag at least 9.5 inches higher than the primary bag fluid level, and all of the clamps closed.The secondary set was primed with the secondary roller clamp fully opened.Fluid flow was controlled using the primary roller clamp.After 10 minutes of allowing fluid to flow, the was found to be flowing normally.No blue dye/water mixture fluid from the secondary bag was found to be flowing through the check valve into the primary bag.The customer complaint could not be verified.The failure was unable to be replicated.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review could not be performed on model 2410-0500 because a lot number was not provided by the customer.H3 other text : see h.10.

• Brand Name: AS LVP 20D DEHP 2SS
• 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 22244 ; MX 22244
• MDR Report Key: 11243462
• Report Number: 9616066-2021-50112
• Device Sequence Number: 3571862
• Product Code: FPA
• UDI-Device Identifier: 07613203012492
• UDI-Public: 07613203012492
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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 Catalogue Number: 2410-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10016073 - SEC SET 20DP W/HANGER LL DEHP FREE; 10016073 - SEC SET 20DP W/HANGER LL DEHP FREE