MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET; 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	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ low sorbing infusion set tubing detached from the drip chamber while preparing it for use.The following information was provided by the initial reporter: "drip chamber detached from tubing while prepping for use.".
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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 31-may-2023 h6: investigation summary one used sample of material number 10013072 was submitted for quality investigation.It was reported by the customer that the drip chamber detached from tubing while prepping for use.Evaluation of the extension set shows that the extension set tube separated from the drip chamber.Further visual inspection shows a lack of solvent on the tubing.Because of separation, priming of set could not be possible.Quality notification send to manufacturer.A device history record review for model 10013072 and 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 of lot.After investigation along with manufacturing and quality operations team, the root cause that generates the issue of separation other component - no leak in model is an incorrect assembly due to the personnel assembling this portion of set not following the procedure.Quality alert was displayed to the personnel involved in the manufacturing of model to reinforce the instructions to perform pieces one at a time and to perform proper segregation.
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ low sorbing infusion set tubing detached from the drip chamber while preparing it for use.The following information was provided by the initial reporter: "drip chamber detached from tubing while prepping for use.".

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17049143
• Report Number: 9616066-2023-01068
• Device Sequence Number: 14297132
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 07613203021210
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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