MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS GEM 20DP V/NV CKV 3SS; INTRAVASCULAR ADMINISTRATION SET

Model Number	2429-0500
Medical Device Problem Codes	Material Separation (1562); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris gem 20dp v/nv ckv 3ss the pump alarmed for air in the line and then separated between the pump and safety clamp.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the alaris pump alarmed for "air in line on 3 occasions and on the third occasion, the tubing broke at the junction of the pump segment and safety clamp.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 08-jun-2022.H6: investigation summary a sample was received and investigated by our quality team.The tubing was separated at the upper fitment of pump segment and the customer's complaint has been verified.The retaining ring was preserved and there was evidence of proper assembly.The tubing and retaining ring were measured with calipers and conformed with manufacturer specifications.This issue has been seen in the past as a root cause- use error when excessive tensile force is applied when loading.A device history record review for model 2429-0500 lot number 20015398 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10jan2020.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.H3 other text : see h10.
Event or Problem Description
It was reported while using bd alaris gem 20dp v/nv ckv 3ss the pump alarmed for air in the line and then separated between the pump and safety clamp.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the alaris pump alarmed for "air in line on 3 occasions and on the third occasion, the tubing broke at the junction of the pump segment and safety clamp.

• Brand Name: BD ALARIS GEM 20DP V/NV CKV 3SS
• 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: 14366009
• Report Number: 9616066-2022-00585
• Device Sequence Number: 1958956
• Product Code: FPA
• UDI-Device Identifier: 50885403228016
• UDI-Public: 50885403228016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 08/26/2022

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: Health Professional
• Device Expiration Date: 01/10/2023
• Device Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Device Lot Number: 20015398
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2020
• 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