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

Model Number 2420-0007

Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889); Material Too Soft/Flexible (4007)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing was easily bent and kinked, causing flow issues.This occurred at least once each in lots 23015527 and 22115227.The following information was provided by the initial reporter: "tubing bends and crimps too easily.Was any medication used with the product? if yes, what was the medication? oxytocin; could you clarify if you mean that the tubing is received already kinked, or does the tubing remain kinked after crimping or bending the tubing? tubing kinks and remains kinked with bending; are you noticing that the kinking is causing flow issues? yes".

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 23015527; d.4.Medical device expiration date: 23-jan-2026; h.4.Device manufacture date: 19-jan-2023; d.4.Medical device lot #: 22115227; d.4.Medical device expiration date: 07-nov-2025; h.4.Device manufacture date: 04-nov-2022; h.4.Device manufacture date: unknown.

Manufacturer Narrative

Investigation summary: one video was submitted of an infusion set with tubing kinked.The customer complaint of tubing kinked was confirmed after investigation of the video submitted.The video of the infusion set shows that there are kinks in the tubing at a union between a y-site smartsite input port and the tubing, as well as a kink in the tubing at the outlet port of the drip chamber and tubing union location.A device history record review for model 2420-0007 lot number 22115227was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Based on the evaluation of the video provided by the customer, the root cause of the kinks seen in the video can be attributed to an incorrect assembly process.The manufacturing location was made aware, and an investigation was conducted for the failure.It was determined that the root cause was due to incorrect coiling of the infusion set.The assembler was not using an approved method of coiling the infusion sets and therefore causing kinks in the tubing during packaging.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing was easily bent and kinked, causing flow issues.This occurred at least once each in lots 23015527 and 22115227.The following information was provided by the initial reporter: "tubing bends and crimps too easily.Was any medication used with the product? if yes, what was the medication?: oxytocin could you clarify if you mean that the tubing is received already kinked, or does the tubing remain kinked after crimping or bending the tubing? tubing kinks and remains kinked with bending.Are you noticing that the kinking is causing flow issues? yes.".

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ 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: 16943495
• MDR Text Key: 315847884
• Report Number: 9616066-2023-00919
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 07613203021012
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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