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

Catalog Number 11532269

Device Problem Failure to Disconnect (2541)

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

Event Date 08/07/2023

Event Type  malfunction  

Event Description

It was reported that bd bd alaris pump module smartsite low sorbing infusion set failure to disconnect.The following was provided by the initial reporter with the verbatim: hospital is stating that they use this set for tpn¿s.They are stating that it is getting stuck in their picc lines when trying to remove it.They are having to use hemostats or cut the line for removal.This is happening at multiple campuses.They are requesting on site visit to resolve issue and/or educate nursing on proper practice.The site is using the set to administer tpn/lipids (clinimix w smof lipids.The smof piece is new) and connecting directly to the hub of the catheter, not using any type of connector (clave, mz, etc.).The set is getting ¿bonded¿ or stuck on the hub and they are having to cut the tubing to get it off or change out the lines.I am not sure if the smof piece carries more glucose or gluconate that could be causing a binding of sorts to the hub? i know smof lipids do bad stuff to our pediatric filters but haven¿t heard of this.1.Why is low sorb tubing being used for your tpn¿s?: low sorb tubing is used to reduce the occurrence of tpn components binding to the tubing: insulin and certain vitamins most notable.2.Did you recently change to this set?: we are using the same tubing we have been using for at least a year.3.Any recent changes to composition of tpn¿s?: no changes to tpn composition: using baxter clinimix products.The only change is the addition of smoflipid which is an intralipid product used rarely on certain patients.4.What type of connector is used with this set?: we are directly connecting to the port.No needleless connectors being used.5.Did you change product used to swab with (i.E.Change from alcohol to chg wipes)?: no we have not recently changed swabs.

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17752915
• MDR Text Key: 324082386
• Report Number: 9616066-2023-01891
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232341
• UDI-Public: (01)50885403232341
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11532269
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• 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