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

Catalog Number	2420-0500
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
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 smartsite infusion set was damaged the following information was received by the initial reporter with the following verbatim.Chemo infusion was about to start, the chemo (cyclophosphamide) started to drip and was filling the primary ns i.V.Bag, which was lower than the chemo bag.This should never happen as the primary set was the alaris pump (locked in) primary line set roller was also clamped.
Additional Manufacturer Narrative
It was reported by the customer that the chemo (cyclophosphsmide) started to drip and was filling the primary ns i.V.Bag, which was lower than the chemo bag.One sample was received for quality investigation.Visual inspection was conducted and no damages or abnormalities were identified.The infusion set was primed and no leakage, air-in-line or occlusion issues were found.A bd secondary infusion line was primed and attached to the submitted sample, and a simulated infusion was conducted at a rate of 125 ml/hr.There was no backflow of fluid from the secondary infusion bag to the primary infusion line.The lower roller clamp of the primary set was then engaged in order to try and replicate the reported issue by the customer.The failure could not be replicated.The customer complaint of clamp issues / damaged was not replicated.A root cause was not determined because the failure was not replicated.A device history record review for model 2420-0500 lot number 24083011 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
Material: 2420-0500.Batch#: 24083011.It was reported by the customer that the chemo (cyclophosphsmide) started to drip and was filling the primary ns i.V.Bag, which was lower than the chemo bag.Rcc received a complaint via email.Chemo infusion was about to start, the chemo (cyclophosphsmide) started to drip and was filling the primary ns i.V.Bag, which was lower than the chemo bag.This should never happen as the primary set was the alaris pump (locked in) primary line set roller was also clamped.Manufacturer code/model: 2420-0500.Serial or lot number: (b)(6).

• 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: 20881882
• Report Number: 9616066-2024-01963
• Device Sequence Number: 18123150
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: (01)07613203012430
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 2420-0500
• Device Lot Number: 24083011
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown