MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP BLD180M 15D DEHP; INTRAVASCULAR ADMINISTRATION SET

Model Number	10015414
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ lvp bld180m 15d dehp experienced leakage.The following information was provided by the initial reporter: tubing leaked from the filter chamber - just where the iv tubing connects to the filter.Infusion stopped, and new tubing had to be primed and used for the transfusion to continue.How long was product in use when the problem occurred? 5 min.How was it detected? blood was leaking at drip chamber onto floor.
Additional Manufacturer Narrative
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 the bd alaris¿ lvp bld180m 15d dehp experienced leakage.The following information was provided by the initial reporter: tubing leaked from the filter chamber - just where the iv tubing connects to the filter.Infusion stopped, and new tubing had to be primed and used for the transfusion to continue.How long was product in use when the problem occurred? 5 min.How was it detected? blood was leaking at drip chamber onto floor.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 04-jan-2023.H6: investigation summary: a sample was received and investigated by our quality team.The leak described by customer was noticed as soon as saline solution was infused through the set.The set leaked where tubing enters above drip chamber and verified the leakage complaint.The manufacturing team was contacted about this issue for further investigation into root cause/ if this failure could be traced back to an assembly issue.The manufacturer determined that this leakage was caused by improper application of solvent during the assembly of the drip chamber to tubing portion at the manufacturing facility.There have been documents added to standard operating procedure to eliminate further occurrences of this issue.A device history record review for model 10015414 lot number 22066316 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.

• Brand Name: BD ALARIS¿ LVP BLD180M 15D DEHP
• 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: 16020118
• Report Number: 9616066-2022-02020
• Device Sequence Number: 14917634
• Product Code: FPA
• UDI-Device Identifier: 50885403233997
• UDI-Public: 50885403233997
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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: 06/27/2025
• Device Model Number: 10015414
• Device Catalogue Number: 10015414
• Device Lot Number: 22066316
• 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: 12/02/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 03/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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