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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
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.Please be advised that we¿re having issues with the tubing for the bd infusion pumps, as per the below.This is quite concerning as this has occurred several times now.The batch number for the tubing is shown below.We would like this reviewed as soon as possible and the problem identified whether it¿s just pertaining to the tubing or the pump as well.The entire batch would need to be replaced at no cost to (b)(6) if the batch is found to be defective.Patient on tpn.We primed the line, clamped it, then the tpn solution started dropping out and the filter got drained.We tried with x2 tubing with the same result.Possible defective tubing? new tubing set from medicine unit used without issue.Tubing: db alaris pump infusion set 1.2micron filter lot-23085143.
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
Investigation summary: it was reported that the tpn was leaking from the filter.One sample model 2202-0007, lot 23085143 was returned for investigation.The set was examined for defects and abnormalities.The vents on the filter were wetted out.No other defects or abnormalities were observed.The set was flushed with water and leakage was seen coming from the filter vent.Additional air under water test was performed.The set was pressurized with about 10psi and the vent was submerged under water.There was a steady stream of air bubbles coming from the filter vent.This would indicate that there is no issue with damage/ holes in the membrane.The reason for the membrane leaking is that the hydrophobicity of the membrane must have been compromised during use and not during the manufacturing process.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Sample received.

• 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: 21649324
• Report Number: 9616066-2025-00584
• Device Sequence Number: 7424487
• Product Code: FPA
• UDI-Device Identifier: 10885403274039
• UDI-Public: (01)10885403274039(11)230804(17)260804(10)23085143
• 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): 03/26/2025

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 Expiration Date: 08/04/2026
• Device Catalogue Number: 2202-0007
• Device Lot Number: 23085143
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 03/26/2025
• 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