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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
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: i have received a product failure form dated (b)(6) 2024 for a secondary tubing incident in which the secondary set pulled from the main tubing line rather than the secondary set.We are currently working with a large group of bd folks on some free flow issues and are reviewing the tubings as well.This was another incident that could not be determined what happened.I do not have the lot #¿s of the two sets involved in this but suspect the catalog numbers are¿ 2420-0007 for the primary set, and the secondary set if most likely cat# ms3500-15.They are still all intake with the setup as it was when the error was reported and we would like to have this sent back for review.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported the primary and secondary setup was working incorrectly, and only pulling from the primary.Two sets were returned, primary 2420-0007 and secondary ms3500-15, no lots.The set was visually examined for defects and abnormalities.No defects or abnormalities were observed.The sets were then infused in normal primary/secondary setup, and no issues were observed.The secondary is infused with blue dye water, and the primary regular tap water.The back check valve and otherwise full set was operating normally.Complaint could not be verified.A root cause is not able to be found without a replicated failure.A device history record review could not be performed on material ms3500-15 because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• 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: 18784663
• Report Number: 9616066-2024-00308
• Device Sequence Number: 8297312
• 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): 08/28/2024

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown