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

Catalog Number	2202-0007
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2024
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 infusion set was damaged the following information was received by the initial reporter with the following verbatim description as reported : (b)(4) cust.Lodged multiple complaints re: material 2202-0007.1ea reported as tubing noted to have hole in it when priming lipids.Not used on patient, no harm.1ea reported large amount of air in tubing after going through filter + close to patient.This amount of air could be life threatening to the patient.Occurred while in use with patient, no serious injury/harm done but near miss.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Sample investigation and dhr.The customer reported air in line past the filter, and returned one used sample of material 2202-0007, lot 23085143.Upon initial visual examination, the set had no defects or abnormalities.The set was then infused with water, and the leak was found form the middle of tubing in between the filter and pump segment.Complaint of tubing leak verified.After investigation, the damage in the tubing reported by the customer could not be replicated in the production process.The failure mode was not found to be related to the manufacturing process, and the root cause is unknown.Device history record review for model 2202-0007 lot number 23085143 was performed.The search showed that a total of 26,883 units in 1 lot number was built on 09aug2023.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: BD ALARIS PUMP MODULE 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: 19134748
• Report Number: 9616066-2024-00604
• Device Sequence Number: 14617164
• Product Code: FPA
• UDI-Device Identifier: 10885403274039
• UDI-Public: (01)10885403274039
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/05/2024

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 Expiration Date: 08/04/2026
• Device Catalogue Number: 2202-0007
• Device Lot Number: 23085143
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown