MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 105"ADMIN SET 20DP, W/2 Y SITE, CV CLMPS; INTRAVASCULAR ADMINISTRATION SET

Model Number	B2-70072
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that 105"admin set 20dp, w/2 y site, cv clmps had blood backflow.This occurred on 2 occasions.The following information was provided by the initial reporter: material no: b2-70072, batch no: 20085276.It was reported the secondary set backed up into the primary set.
Event or Problem Description
It was reported that 105"admin set 20dp, w/2 y site, cv clmps had blood backflow.This occurred on 2 occasions.The following information was provided by the initial reporter: material no: b2-70072, batch no: 20085276.It was reported the secondary set backed up into the primary set.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-05-25.H6: investigation summary: a device history review was conducted for lot number 20085276.Two sample sets received.Two materials model b2-70072 primary sets and two secondary infusion tubing sets were tested with a customer¿s complaint of back flow into primary set through a check valve.The sets were photographed by customer in the correct ¿piggyback¿ secondary infusion organization so an incorrect assembly was not suspected.The photographs showed clear evidence of backflow of the secondary medication (brown) into the primary fluid (clear/colorless) which verified the customer¿s complaint.To test the sets, a blue dye solution was infused through the secondary set at a high infusion rate (200ml/hr) and a saline solution through the primary.Both separate sets were tested in this manner and no backflow was observed after an hour of infusion.After this, for testing purposes, an attempt was made to force backflow using blue dye in a syringe (through smartsite port) and the primary set¿s roller clamp closed.This type of pressure has been known to force backflow in the past.Multiple attempts were made but only one backflow was successful with only one set.Root cause definition: the condition reported by customer under this complaint was confirmed (based on how the customer reported the issue), however, the samples were tested, and no backflow were observed in the samples after an hour of infusion and before the attempt to force it, therefore, the root cause could not be confirmed.H3 other text : see h10.

• Brand Name: 105"ADMIN SET 20DP, W/2 Y SITE, CV CLMPS
• 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: 11891519
• Report Number: 9616066-2021-51167
• Device Sequence Number: 3710069
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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 Expiration Date: 08/04/2023
• Device Model Number: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: 20085276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 05/26/2021
• 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