MAUDE Adverse Event Report: ALARIS PUMP MODULE SMARTSITE INFUSION SET; PUMP INFUSION SET

Model Number 2426-0007

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

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

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).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 that alaris pump module smartsite infusion set was clogged.The following information was provided by the initial reporter: "it was reported by the customer that the iv ports were jammed.".

Manufacturer Narrative

H.6.Investigation: two photos were returned by the customer.It was reported that the iv ports were jammed.The photos show the product in its packaging, however, they do not verify the complaint.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 2426-0007 lot number 21026103 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 this failure was not identified as no product was returned.

Event Description

It was reported that alaris pump module smartsite infusion set was clogged.The following information was provided by the initial reporter: "it was reported by the customer that the iv ports were jammed.".

• Brand Name: ALARIS PUMP MODULE SMARTSITE INFUSION SET
• Type of Device: PUMP INFUSION SET
• MDR Report Key: 12455173
• MDR Text Key: 270919061
• Report Number: 9616066-2021-52013
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403227996
• UDI-Public: 50885403227996
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/13/2024
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 21026103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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