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

Model Number	2942-0500
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported bd alaris¿ pump module infusion set suffered from component separation, resulting in leakage.The following information was provided by the initial reporter: ".A1203 - disconnection a050401 - fluid leak.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical 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.
Additional Manufacturer Narrative
H.6.Investigation summary: no photo or sample was received for the customer's complaint of separation with leak.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
It was reported bd alaris¿ pump module infusion set suffered from component separation, resulting in leakage.The following information was provided by the initial reporter: ".A1203 - disconnection a050401 - fluid leak.".

• Brand Name: BD ALARIS¿ PUMP MODULE INFUSION SET
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14354968
• Report Number: 9616066-2022-00576
• Device Sequence Number: 11781490
• Product Code: FPA
• UDI-Device Identifier: 50885403232389
• UDI-Public: 50885403232389
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: CA
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: Health Professional
• Device Model Number: 2942-0500
• Device Catalogue Number: 2942-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown