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	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris secondary set was over infusing the following information was received by the initial reporter with the following: it was reported by the customer that cefepime in a 100ml bag was scheduled to run over 4 hours at 25ml/hr.Medication was scheduled to end at 1739.Rn returned to the room around 1500 and the bag of cefepime was empty.
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
Updated event type and ar code.
Event or Problem Description
It was reported that bd alaris secondary set was damaged the following information was received by the initial reporter with the following verbatim it was reported by the customer that cefepime in a 100ml bag was scheduled to run over 4 hours at 25ml/hr.Medication was scheduled to end at 1739.Rn returned to the room around 1500 and the bag of cefepime was empty.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of tubing defective / damaged could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material ms3500-15 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Mdr made in error it is (b)(4) is the concomitant of (b)(4).
Event or Problem Description
Cancel.

• 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: 20989156
• Report Number: 9616066-2024-02084
• Device Sequence Number: 12878336
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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,Followup,Followup
• Report Date (Section B): 02/26/2025

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: 12/05/2024
• Supplement Date Received by Manufacturer: 02/06/2025; 02/11/2025; 02/26/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 02/06/2025; 02/11/2025; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown