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 Problems Partial Blockage (1065); Improper Flow or Infusion (2954)

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

Event Date 08/17/2022

Event Type  malfunction  

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 7 bd alaris¿ pump module smartsite¿ low sorbing infusion sets had flow issues during use.The following information was provided by the initial reporter: "observed the following incident six times today and nurses report that it has been happening in the past 1-2 weeks.Bd alaris system pump modules alarming "occluded - fluid side" and either the drip chamber was "vacuumed" or "sucked" in or the empty bag was vacuumed/sucked in (but not both).Witnessed with different medications, with different tubing sets (2426-0500, 2260-0500, 11532269), with chemolock product.And without.No changes in compounding practices or nursing infusion practices reported.No patient impact.".

Event Description

It was reported that 7 bd alaris¿ pump module smartsite¿ low sorbing infusion sets had flow issues during use.The following information was provided by the initial reporter: "observed the following incident six times today and nurses report that it has been happening in the past 1-2 weeks.Bd alaris system pump modules alarming "occluded - fluid side" and either the drip chamber was "vacuumed" or "sucked" in or the empty bag was vacuumed/sucked in (but not both).Witnessed with different medications, with different tubing sets (2426-0500, 2260-0500, 11532269), with chemolock product.And without.No changes in compounding practices or nursing infusion practices reported.No patient impact.".

Manufacturer Narrative

After further review, this complaint has been determined to be not reportable, since this incident will not lead to serious injury or death.Please consider mdr mfr# (b)(4)cancelled.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15414665
• MDR Text Key: 305885358
• Report Number: 9616066-2022-01325
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232343
• UDI-Public: 10885403232343
• 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: 09/15/2022

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: Health Professional
• Device Catalogue Number: 11532269
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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