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

Model Number 22603-B007T

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2023

Event Type  malfunction  

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 Description

It was reported while using bd alaris pump module smartsite texium low sorbing infusion set there were cracks and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we were able to deduce that the lines actually appear to have a crack in the lines where it is leaking from.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 04-may-2023.H6: investigation summary: a complaint of tubing having a crack and leaking was received from the customer.Three samples, two unopened and one used, were returned for investigation.Through visual inspection, no defects or damages were observed.The used set was then primed, and leakage was observed from a cut in the tubing.When looking at the tubing under the microscope, it was a clean cut.The customer complaint was confirmed.A device history record review for model 22603-b007t lot number 22075599 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.

Event Description

It was reported while using bd alaris pump module smartsite texium low sorbing infusion set there were cracks and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we were able to deduce that the lines actually appear to have a crack in the lines where it is leaking from.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET
• Type of Device: 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: 16456945
• MDR Text Key: 310423815
• Report Number: 9616066-2023-00281
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403240940
• UDI-Public: (01)50885403240940
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 22603-B007T
• Device Catalogue Number: 22603-B007T
• Device Lot Number: 22075599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1