MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS¿ LVP 20D LOW SORB 2SS CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10013072
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during use with bd alaris¿ lvp 20d low sorb 2ss cv the tubing set separated below the drip chamber.This is the 4th of 4 instances.The following information was provided by the initial reporter: it was reported by customer that they have had 4 tubing set failures with the attached bd optima cstd in the oncology infusion center.(b)(6) 2023 bd alaris pump infusion set low sorbing tubing (pe lined) back check valve, two smartsite y-sites: ref: 10013072.Lot: (10)22115368 exp: 2025-11-17.Docetaxel.Below drip chamber failure ¿ tubing bond failure.
Event or Problem Description
It was reported that during use with bd alaris¿ lvp 20d low sorb 2ss cv the tubing set separated below the drip chamber.This is the 4th of 4 instances.The following information was provided by the initial reporter: it was reported by customer that they have had 4 tubing set failures with the attached bd optima cstd in the oncology infusion center.On (b)(6) 2023 bd alaris pump infusion set low sorbing tubing (pe lined) back check valve, two smartsite y-sites.Ref: 10013072.Lot: (10)22115368 exp: 2025-11-17.Docetaxel.Below drip chamber failure ¿ tubing bond failure.
Additional Manufacturer Narrative
Investigation summary: three photos were received for the customer's complaint of separation.The photos clearly show the separation between different tubing and verify the failure.The manufacturing plant was contacted to investigate further, and find a possible root cause.The most likely root cause is due to personnel incorrectly following assembly procedure at time of assembly.There has been two quality notifications initiated before the receipt of this complaint.First- to reinforce the segregation of materials that do not fit correct dimensions (ie tubing that fall outside of specified inner/outer diameter) before assembly.The second was a meeting with assembly team to further train on the instructions of assembly.These changes occurred after the production of this set but were initiated to eliminate further occurrences of this failure.The exact root cause of separation is unknown without a physical sample for investigation.Device history record review for model 10013072 lot number 22115368 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS¿ LVP 20D LOW SORB 2SS CV
• 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: 17350216
• Report Number: 9616066-2023-01485
• Device Sequence Number: 12129251
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 07613203021210
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 11/17/2025
• Device Catalogue Number: 10013072
• Device Lot Number: 22115368
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2022
• 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