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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
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 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 they noticed a small crack of the tpn buretrol tubing underneath the drip chamber.
Additional Manufacturer Narrative
It was reported that there was a small crack below the drip chamber causing a leak.One sample model 10015012 was returned for investigation.The set was examined for defects and abnormalities.A tear in the tubing below the drip chamber was observed.No other defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the root cause of excess of solvent is due to an incorrect solvent application by the assembler and/or failures in solvent dispenser.The standard work instruction has been updated on september 05th, 2024 to define that when the spare part or part to be worked on comes into contact with the product, a maintenance work order must be generated at the time the event occurs.Additionally, a quality alert was created on october 31st, 2024 and communicated by the production supervisor to the production personnel to reinforce the correct assembly between tubing and bottom cap chamber.A device history record review could not be performed because a lot number was not provided by the customer.

• 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: 21334330
• Report Number: 9616066-2025-00163
• Device Sequence Number: 20969941
• 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): 04/04/2025

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
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/07/2025
• 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