MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP GEM V/NV 20D 0.2 FLTR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2232-0007
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ lvp gem v/nv 20d 0.2 fltr tubing had foreign matter that was found.The following information was provided by the initial reporter: " lot : (10) 21125446.Patient's medication spiked with tubing.This rn noted a hair to be stuck in the tubing near the vent door.Tubing removed and new tubing used for medication.Lot: unknown.Rn assessing the line and noticed a puddle of lipids on the equipment as well as on the iv pole.I checked the connections and then opened the door to the chamber and there was a hole in the tubing that was spraying lipids everywhere.".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
One sample model 2232-0007 lot unknown was returned for investigation.The sets were examined for defects and abnormalities.A cut in the tubing was found below the alaris pump clamp.No other defects or abnormalities were observed.The set was attached to an iv bag filled with water and a leak was observed coming from the cut.The customer complaint that there was a leak was confirmed.A quality notification was sent to the manufacturer.From the manufacturer's investigation, the damage in the tubing reported by the customer could not be replicated in the production process and no opportunities were found in the manufacturing of the model and affected tubing.Additionally, based on the photo provided by the vh dchu and customer words it seems that the damage was created during the use, due to this, the failure mode was not found to be related to the tijuana manufacturing process.No corrective or preventive actions were taken for this complaint because the potential root cause was not found to be related to the tijuana manufacturing process.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
No additional info.

• Brand Name: BD ALARIS¿ LVP GEM V/NV 20D 0.2 FLTR
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17935227
• Report Number: 9616066-2023-02090
• Device Sequence Number: 12354406
• Product Code: FPA
• UDI-Device Identifier: 10885403463969
• UDI-Public: (01)10885403463969
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: Health Professional
• Device Expiration Date: 12/22/2024
• Device Catalogue Number: 2232-0007
• Device Lot Number: 21125446
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 01/07/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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