MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP SS BAG 20D LOW SORB; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2466-0007
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Investigation summary: a complaint of pumping segment tubing being flat and not being able to complete infusion was received from the customer.No product or photo was returned by the customer.The customer complaint of tubing defective/ damaged could not be verified due to the product not being returned for failure investigation.A device history record review for model 2466-0007 lot number 21095172 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 02sep2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported while using bd alaris¿ lvp ss bag 20d low sorb the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: upon looking at the tubing, the part that fits into the pump was smashed completely flat.Health care providers called nurse and she had to take the chemo down to pharmacy and replace the tubing.Once this was done, the chemotherapy infused without any difficulty.It was a faulty chemo tubing.

• Brand Name: BD ALARIS¿ LVP SS BAG 20D LOW SORB
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15859254
• Report Number: 9616066-2022-01809
• Device Sequence Number: 12257582
• Product Code: FPA
• UDI-Device Identifier: 10885403221958
• UDI-Public: 10885403221958
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2022

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: 09/02/2024
• Device Catalogue Number: 2466-0007
• Device Lot Number: 21095172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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