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

Model Number 2426-0500

Device Problem Partial Blockage (1065)

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

Event Date 10/27/2022

Event Type  malfunction  

Event Description

It was reported that the bd alaris pump module smartsite infusion set was clogged.The folloring information was provided by the initial reporter: alaris pump infusion set failure tp prime.Ivf bag was spiked and fluid went into drip chamber but would not go any further.Could not get fluid into tubing not even past the back check valve.The safety clamp was open, slide clamp was open and also roller clamp was wide open.I took luer cap off to see if that would help and it would not.Spike was spiked all the way into the bag.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd alaris pump module smartsite infusion set was clogged.The folloring information was provided by the initial reporter: alaris pump infusion set failure tp prime.Ivf bag was spiked and fluid went into drip chamber but would not go any further.Could not get fluid into tubing not even past the back check valve.The safety clamp was open, slide clamp was open and also roller clamp was wide open.I took luer cap off to see if that would help and it would not.Spike was spiked all the way into the bag.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.It was reported by customer that " ivf bag was spiked and fluid went into drip chamber but would not go any further.Could not get fluid into tubing not even past the back check valve." the customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 2426-0500 lot number 22083160 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• 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: 15833263
• MDR Text Key: 307810744
• Report Number: 9616066-2022-01785
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: 37613203021006
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 22083160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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