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

Catalog Number	MS3500-15
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem 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.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
It was reported that the set was unable to flow through the set.Two samples model ms3500-15, lot 23103174 were returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were attached to a bd syringe filled with water and flushed.No fluid blockage was observed.The customer complaint was unable to be replicated.The root cause could not be determined because the issue could not be replicated.

• Brand Name: BD ALARIS SECONDARY 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19170002
• Report Number: 9616066-2024-00605
• Device Sequence Number: 18106834
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: MS3500-15
• Device Lot Number: 23103174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown