MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SECONDARY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MS3500-15

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris secondary set had flow issues.The following information was received by the initial reporter with the following verbatim: the first occurred on 3/20/24 ¿ cat# ms3500-15, lot# (10)23103174- drug keppra was not running, pulling from primary bag.

• Brand Name: BD ALARIS SECONDARY SET
• Type of Device: 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19170002
• MDR Text Key: 341711664
• Report Number: 9616066-2024-00605
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MS3500-15
• Device Lot Number: 23103174
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1