MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 86" HALF SET W/1 VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	28117E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 86" half set w/1 vlv port was clogged/blocked/occluded.The following information was provided by the initial reporter material #: 28117e, batch/lot #: 20076813.We have seen a significant increase in cartridge alarms on the pumps.Cassette jams etc.Biomed feels that it may be an issue with the tubing.
Event or Problem Description
It was reported that the 86" half set w/1 vlv port was clogged/blocked/occluded.The following information was provided by the initial reporter material #: 28117e batch/lot #: 20076813 we have seen a significant increase in cartridge alarms on the pumps.Cassette jams etc.Biomed feels that it may be an issue with the tubing.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 2/3/2021 h.6.Investigation: one sample was received for quality investigation.The customer complaint of tubing defective / damaged could not be verified based on testing conducted on the returned sample.The infusion sets were primed and installed into an appropriate pump.The pump did not indicate any issues with the tubing and the pump did not alert of an occlusion or air in line issues.No other issues were identified.A device history record review for model 28117e lot number 20076813 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined because the failure reported could not be reproduced.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of tubing defective / damaged with lot #20076813 regarding item #28117e.

• Brand Name: 86" HALF SET W/1 VLV PORT
• 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: 11341427
• Report Number: 9616066-2021-50248
• Device Sequence Number: 14660386
• Product Code: FPA
• UDI-Device Identifier: 10885403274893
• UDI-Public: 10885403274893
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K874564
• 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): 05/24/2021

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: 07/21/2023
• Device Catalogue Number: 28117E
• Device Lot Number: 20076813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 06/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1