MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	11522558
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris pump module smartsite infusion set experienced air in line.The following information was provided by the initial reporter: ball valve in drip chamber did not appear to work properly.Additional information: did you experience any adverse events as a result of the reported failure? no.Was any medication used with the product? if yes, what was the medication? remicade.(infliximab): could you describe in a little more detail what exactly was wrong with the ball valve? the pump was able to pull air past the ball in the tubing.The pump alarmed when the air hit the pump.Air had to be pulled out via syringe so the remaining medication could be flushed through.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of air being able to be pulled past the ball valve could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 11522558 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.
Event or Problem Description
It was reported that the bd alaris pump module smartsite infusion set experienced air in line.The following information was provided by the initial reporter: ball valve in drip chamber did not appear to work properly.Additional information: did you experience any adverse events as a result of the reported failure? no was any medication used with the product? if yes, what was the medication? remicade (infliximab) could you describe in a little more detail what exactly was wrong with the ball valve? the pump was able to pull air past the ball in the tubing.The pump alarmed when the air hit the pump.Air had to be pulled out via syringe so the remaining medication could be flushed through.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16925113
• Report Number: 9616066-2023-00891
• Device Sequence Number: 6910493
• Product Code: FPA
• UDI-Device Identifier: 10885403232305
• UDI-Public: 10885403232305
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 06/05/2023

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 Catalogue Number: 11522558
• Device Lot Number: UNKNOWN
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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