MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. DEHP FREE 4 IN EXT SET W/ANTSPHN VLV DET; INTRAVASCULAR ADMINISTRATION SET

Model Number	C25012
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the dehp free 4 in ext set w/antsphn vlv det was unable to infuse fluids beyond the attached anti-siphon set due to flow issues/blockage.The following information was provided by the initial reporter: "iv pump beeped indicating occlusion.Iv site intact, flushing easily with no occlusion or obstruction noted.Unable to infuse fluids beyond the anti-siphon extension set which had been attached to the line.Attempted to remove anti-siphon set but same had become stuck in the line.".
Event or Problem Description
It was reported that the dehp free 4 in ext set w/antsphn vlv det was unable to infuse fluids beyond the attached anti-siphon set due to flow issues/blockage.The following information was provided by the initial reporter: "iv pump beeped indicating occlusion.Iv site intact, flushing easily with no occlusion or obstruction noted.Unable to infuse fluids beyond the anti-siphon extension set which had been attached to the line.Attempted to remove anti-siphon set but same had become stuck in the line.".
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of an inability to infuse fluids beyond the anti-siphon extension set and iv pump was indicating occlusion could not be verified due to the product not being returned for failure investigation.A device history record review for model c25012 lot number 20016877 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.

• Brand Name: DEHP FREE 4 IN EXT SET W/ANTSPHN VLV DET
• 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: 11948038
• Report Number: 9616066-2021-51266
• Device Sequence Number: 1085945
• Product Code: FPA
• UDI-Device Identifier: 50885403235618
• UDI-Public: 50885403235618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/10/2021

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: 01/22/2023
• Device Model Number: C25012
• Device Catalogue Number: C25012
• Device Lot Number: 20016877
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1