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

Model Number 2426-0007

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 12/05/2022

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 infusion set the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: our pediatric oncology team opened an infusion set and the tubing is cut.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 19-dec-2023.H6: investigation summary: one sample of material number 2426-0007 was submitted for quality investigation.The customer complaint of tubing defective damage was verified by visual inspection.Visual examination of the sample indicated that the tubing was cut below the lower pumping segment fitting and the c-clamp was damaged.The cut in the tubing was straight through without any indication of excessive stretching or tearing of the material.Additionally, the c-clamp is bent where the clamping mechanism will not engage and there is some damage to the clamping area where there is significant chipping of the clamp material.A device history record review for model 2426-0007 lot number 21039019 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the issue seen in this complaint is an issue created during the manufacturing of the infusion set.The manufacturing location has been informed and an internal investigation is being conducted in order to determine the source of the failure.An investigation was conducted at the manufacturing facility to determine if the crushed clamp and cut tubing could have been created during any step in the manufacturing of the infusion set.After investigation of the assembly process, it was concluded that there are no steps in the manufacturing process that could reproduce the damage seen in the infusion set.The probable cause for the damaged seen on this set is that the set was damaged during transport or storage of the set.There is an unknown external factor that was able to cut the tubing along with crushing the clamp.A quality alert was generated to notify the assembly staff about the damage on the set.H3 other text : see h10.

Event Description

It was reported while using bd alaris pump module smartsite infusion set the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: our pediatric oncology team opened an infusion set and the tubing is cut.

• 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 ; 8015296192
• MDR Report Key: 16030224
• MDR Text Key: 308367824
• Report Number: 9616066-2022-02025
• Device Sequence Number: 1
• Product Code: FPA
• 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: 03/07/2023

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
• Device Operator: Other
• Device Expiration Date: 03/11/2024
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 21039019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• 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