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

Catalog Number	10015012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite burette infusion set was damaged the following information was received by the initial reporter with the following verbatim.It was reported by customer that iv pump alarming air in line.When tubing removed from pump, the tubing broke into two pieces.
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 tubing broke, and returned the sample of material 10015012, lot unknown.The sample was examined, and the complaint of separation at the lower fitment, silicon tubing, was verified.The tubing still had the blue ring retainer on the silicon, and there was a clear indent where the ring retainer was attached.The manufacturing site confirmed that the issue is not related to assembly, with evidence the set was made correctly.The potential root cause is clinical practice, and a member of our clinical team has been notified.A device history record review could not be performed because the lot number is unknown.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE BURETTE 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21263430
• Report Number: 9616066-2025-00089
• Device Sequence Number: 9468474
• Product Code: FPA
• UDI-Device Identifier: 10885403233951
• UDI-Public: (01)10885403233951
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 03/12/2025

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: 10015012
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/13/2025
• 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