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 Improper Flow or Infusion (2954)

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

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd alaris pump module smartsite infusion set experienced flow issues.The following information was provided by the initial reporter: went to see what was taking so long for the secondary infusion to complete, and rn noticed the primary was about dry from infusing and there was still drug in the secondary bag.Cqi data shows correct programming and rn confirmed physical setup was correct.Unclear why secondary bag did not empty.

Event Description

It was reported that the bd alaris pump module smartsite infusion set experienced flow issues.The following information was provided by the initial reporter: went to see what was taking so long for the secondary infusion to complete, and rn noticed the primary was about dry from infusing and there was still drug in the secondary bag.Cqi data shows correct programming and rn confirmed physical setup was correct.Unclear why secondary bag did not empty.

Manufacturer Narrative

H.6.Investigation summary: no product or photo was returned by the customer.It was reported by customer that "when rn went to see what was taking so long for the secondary infusion to complete rn noticed the primary was about dry from infusing and there was still drug in the secondary bag.Unclear why secondary bag did not empty" could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2426-0007 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 22063125.D4: medical device expiration date: 18apr2025.H4: device manufacture date: 18apr2022.D4: medical device lot #: 22063126.D4: medical device expiration date: 18apr2025.H4: device manufacture date: 18apr2022.D10: device available for eval yes, d10: returned to manufacturer on: 16-feb-2023.Investigation summary: one sample ( model # 2426-0007) with primary and secondary set including filter extension set was returned for investigation by the customer.It was reported by customer that the infusion wasn't adequately pulling medication from the secondary bag.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with normal saline and attached to a bd secondary set primed with blue dye water.The set was loaded into an alaris pump and an infusion was started for 1 hr at 125 ml/hr flowing into an empty beaker.It was verified that beaker has about 125 ml in it after infusion completed also the infusion was pulling from the secondary set as expected.No issue of under infusion was replicated.Informational purposes only : dhr performed on basis of potential lots received from supplier.A device history record review for model 2426-0007 and lot number 22063125 was performed.A device history record review for model 2426-0007 and lot number 22063126 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lots.The root cause of this complaint could not be definitively determined because the issue could not be replicated.

Event Description

It was reported that the bd alaris pump module smartsite infusion set experienced flow issues.The following information was provided by the initial reporter: went to see what was taking so long for the secondary infusion to complete, and rn noticed the primary was about dry from infusing and there was still drug in the secondary bag.Cqi data shows correct programming and rn confirmed physical setup was correct.Unclear why secondary bag did not empty.

• 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: 15822627
• MDR Text Key: 303923882
• Report Number: 9616066-2022-01759
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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