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

Catalog Number	10010453
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite low sorbing infusion set separated and leaked.The following information was provided by the initial reporter with the verbatim: verbatim: in the nicu, we had a bd alaris iv tubing break apart at the filter leading to the central line being open ((b)(4)).The reference number is 10010453.Premier number is (b)(4).Could you please give me what the next steps are for submitting the tubing to the rep for inspection? (b)(6) 2023: lot number: unknown.Was there any leakage when this event occurred?: yes because the tubing came apart.Was there any patient involvement?: yes.Any adverse events or serious injury reported to patient or healthcare professional?: no.What was the patient outcome?: the central line was removed.Was there any delay of, or change in, the course of treatment due to this event? : yes.What procedure was being performed?: n/a.What medication was used in the procedure?: n/a.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that bd alaris iv tubing break apart at the filter leading to the central line being open.One sample was submitted for quality investigation.The sample received shows that the tubing had separated from the outlet port of the filter.Further examination under magnification shows that there is an insufficient amount of solvent at the outlet port of the filter and the corresponding tubing that was connected to the port.The customer complaint of separation other component (leak) was verified by visual inspection.The investigation was forwarded to the manufacturing facility.The root cause of the failure could be related to the incorrect solvent application by the assembler or issues with the medical solvent dispenser.To address this issue, the solvent applicator maintenance, preparation and identification procedure was updated with improvements for the cleaning, maintenance and solvent filling of the equipment.Additionally, a quality alert was created and communicated to the involved personnel.A device history record review for model 10010453 lot number 23075366 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15jul2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.
Event or Problem Description
Mat#: 10010453.Batch#: unknown.It was reported by customer that bd alaris iv tubing break apart at the filter leading to the central line being open.Verbatim: in the nicu, we had a bd alaris iv tubing break apart at the filter leading to the central line being open (ireport (b)(4)).The reference number is (b)(4).Premier number is (b)(4).Could you please give me what the next steps are for submitting the tubing to the rep for inspection? on 06oct2023.Lot number: unknown.Was there any leakage when this event occurred? yes because the tubing came apart.Was there any patient involvement? yes.Any adverse events or serious injury reported to patient or healthcare professional? no.What was the patient outcome? the central line was removed.Was there any delay of, or change in, the course of treatment due to this event? yes.What procedure was being performed? n/a.What medication was used in the procedure? n/a.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING 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: 17917419
• Report Number: 9616066-2023-02053
• Device Sequence Number: 15149165
• Product Code: FPA
• UDI-Device Identifier: 37613203021143
• UDI-Public: (01)37613203021143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/29/2024

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: 10010453
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown