MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 130 IN 15 DROP IV ADMIN SET W/4; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX9433
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
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 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 130 in 15 drop iv admin set w/4 had flow issues.This occurred on 1172 occasions.The following information was provided by the initial reporter: it was reported by the customer that the medication flows down toward the patient instead of going upstream into the drip chamber while the iv is running.
Event or Problem Description
It was reported that 130 in 15 drop iv admin set w/4 had flow issues.This occurred on 1172 occasions.The following information was provided by the initial reporter: it was reported by the customer that the medication flows down toward the patient instead of going upstream into the drip chamber while the iv is running.
Additional Manufacturer Narrative
H.6.Investigation: a complaint of fluid flowing the wrong direction, and a suspected misassembly of the filter was received from the customer.5 samples were returned for investigation.All samples were visually inspected and compared to assembly drawings to see any misassemblies.All components were assembled correctly on all five sets.These sets were then primed and infused.No issues were seen on any of the five sets.The customer complaint could not be replicated.A device history record review for model mx9433 lot number 20126027 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 as the failure could not be replicated.A complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of unregulated flow/ misassembly with lot #20126027 regarding item mx943.

• Brand Name: 130 IN 15 DROP IV ADMIN SET W/4
• 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: 11931345
• Report Number: 9616066-2021-51243
• Device Sequence Number: 14227800
• Product Code: FPA
• UDI-Device Identifier: 10885403237782
• UDI-Public: 10885403237782
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 06/08/2021

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: 12/10/2025
• Device Catalogue Number: MX9433
• Device Lot Number: 20126027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1