MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. ALARIS PUMP MODULE AMBER INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2203-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: an invalid lot # of (10)19106851 was provided.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that an unspecified number of alaris pump module amber infusion sets experienced component separation.The following information was provided by the initial reporter: customer stated the product ¿broke into 2 pieces while fluid was running through it¿.Doe is (b)(6) 2020, and was stated the incident happened during use.Customer had no further information.
Event or Problem Description
It was reported that an unspecified number of alaris pump module amber infusion sets experienced component separation.The following information was provided by the initial reporter: customer stated the product ¿broke into 2 pieces while fluid was running through it¿.Doe is (b)(6) 2020, and was stated the incident happened during use.Customer had no further information.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of the model 2203-0500 infusion set breaking in two while using it could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2203-0500 because an invalid lot number was provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: ALARIS PUMP MODULE AMBER INFUSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10311940
• Report Number: 9616066-2020-02276
• Device Sequence Number: 16775643
• Product Code: FPA
• UDI-Device Identifier: 07613203019200
• UDI-Public: 7613203019200
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 2203-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/25/2020
• 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: 20200626; 20200626; 20200626
• Outcome Attributed to Adverse Event: Other