MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. ADD-ON BURETTE SS VLV PS BALL VLV; INTRAVASCULAR ADMINISTRATION SET

Model Number	82115E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 2 add-on burette ss vlv ps ball vlv leaked during use.The following was reported by the initial reporter: "fault with 2 burettes the problem appears to be similar.Burette 1 - leaked when air inlet closed or opened, also when trying to refill burette.When on continuous infusion with air inlet closed burette filled and then leaked out the medication port.Burette 2 - set primed air inlet closed (placed in alaris pump) left standing for 1-2 hours awaiting new admission, later found burette filled and leaking from air inlet and medication port and bottom of burette.Unknown".
Additional Manufacturer Narrative
H.6.Investigation: two 82115e samples were received for investigation with residual fluid present inside the sets; no packaging was received with the samples, however a review of the laser id from the smartsite components confirmed a possible lot number to be 20096120.Additionally, each set was received connected to a 1000ml freeflex glucose iv bag and to a 63401eb gp set to assist the investigation.A visual inspection of one of the returned 82115e samples identified a pinhole in the piston of the smartsite component; leakage was confirmed from the damaged smartsite after a flush through.A visual inspection of the second returned 82115e sample did not identify any signs of damage or manufacturing defect which could have contributed to the customer's experience.The sample was then subjected to pressure testing; no fluid leakage was observed from any point of the infusion set throughout testing.A review of the production records for lot: 20096120 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A definitive root cause for the leakage could not be determined in this instance.
Event or Problem Description
It was reported that 2 add-on burette ss vlv ps ball vlv leaked during use.The following was reported by the initial reporter: "fault with 2 burettes the problem appears to be similar.Burette 1 - leaked when air inlet closed or opened, also when trying to refill burette.When on continuous infusion with air inlet closed burette filled and then leaked out the medication port.Burette 2 - set primed air inlet closed (placed in alaris pump) left standing for 1-2 hours awaiting new admission, later found burette filled and leaking from air inlet and medication port and bottom of burette.Unknown".

• Brand Name: ADD-ON BURETTE SS VLV PS BALL VLV
• 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
• MDR Report Key: 11441175
• Report Number: 9616066-2021-50415
• Device Sequence Number: 14545270
• Product Code: FPA
• UDI-Device Identifier: 37613203009585
• UDI-Public: 37613203009585
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K780130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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 Model Number: 82115E
• Device Catalogue Number: 82115E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1