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

Catalog Number	11522558
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 infusion set had air in line the following information was received by the initial reporter with the following verbatim: you should have received information about an issue with iv tubing last week.I have the bd alaris pump infusion set with ball valve.The product has a ball in the drip chamber that prevents air entering the line as it forms a suction/seal was the medication leaves the drip chamber into the tubing.On 4/11/24 this tubing was used priming a methotrexate infusion by chemotherapy pharmacy.The valve was upright but air managed to enter the line past the ball as it was sitting in the ball valve as intended.No patient harm occurred as the nurses intervened to admin all the methotrexate and the chemo error taskforce has yet to categorize the midas.
Additional Manufacturer Narrative
The customer reported air in line past ball stopper, and returned one sample of material 11522558, lot 23115179.Upon initial visual examination, the set had no defects or abnormalities.The set was infused with water, and the ball valve was working correctly.The complaint could not be verified, the ball valve stopped the flow.Device history record review for model 11522558 lot number 23115179 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10nov2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the incident could not be found without a replication of the failure.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 PUMP MODULE SMARTSITE 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: 19306126
• Report Number: 9616066-2024-00729
• Device Sequence Number: 12371625
• Product Code: FPA
• UDI-Device Identifier: 10885403232305
• UDI-Public: (01)10885403232305
• 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
• Report Date (Section B): 06/13/2024

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: 11522558
• Device Lot Number: 23115179
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/21/2024
• 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