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

Catalog Number 20027E

Device Problems Partial Blockage (1065); Complete Blockage (1094)

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

Event Date 03/23/2023

Event Type  malfunction  

Event Description

It was reported that 2 bd alaris¿ smartsite¿ extension sets clogged at the filter during the docetaxel infusion.The following information was provided by the initial reporter: "we currently infuse multiple medications through this extension set.We've never had any issues up until last week on (b)(6) 23 when we started a new patient on a tchp regimen.During the docetaxel infusion we kept having line occlusion warnings on our bd alaris infusion pump.It appeared the medication kept clogging the filter.The docetaxel was mixed at proper concentration and as previously stated we've never had this kind of problem before was the tubing set attached to a patient at the time of the event or occurred during preparation/priming? attached to the patient.Was the tubing still coiled with tape in place during priming/flushing? no.How much fluid is in the drip chamber prior to priming the rest of the set? i don't know an exact amount but would assume ¾ full.Could you please advise if the filter partially or completely clogged? partially.What steps do you take to help when you do not see flow? massage tubing, squeeze infusion bag, other technique? trace the line from the bag to the patient ensuring the line is free of any clamps or kinks.Which one of these, if any, helps the fluid flow.In this case, none as the line was found to be free flowing and open.".

Manufacturer Narrative

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

Manufacturer Narrative

Correction h5: imdrf annex a grid: 140902.

Event Description

It was reported that 2 bd alaris¿ smartsite¿ extension sets clogged at the filter during the docetaxel infusion.The following information was provided by the initial reporter: "we currently infuse multiple medications through this extension set.We've never had any issues up until last week on (b)(6) 2023 when we started a new patient on a tchp regimen.During the docetaxel infusion we kept having line occlusion warnings on our bd alaris infusion pump.It appeared the medication kept clogging the filter.The docetaxel was mixed at proper concentration and as previously stated we've never had this kind of problem before.Was the tubing set attached to a patient at the time of the event or occurred during preparation/priming? attached to the patient.Was the tubing still coiled with tape in place during priming/flushing? no.How much fluid is in the drip chamber prior to priming the rest of the set? i don't know an exact amount but would assume ¾ full.Could you please advise if the filter partially or completely clogged? partially.What steps do you take to help when you do not see flow? massage tubing, squeeze infusion bag, other technique? trace the line from the bag to the patient ensuring the line is free of any clamps or kinks.Which one of these, if any, helps the fluid flow.In this case, none as the line was found to be free flowing and open.".

Manufacturer Narrative

Investigation summary: no product or photo was returned by the customer.It was reported by the customer that they kept having line occlusion warnings on bd alaris infusion pump, it appeared the medication kept clogging the filter.The customer complaint could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 20027e lot number 22099443 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

It was reported that 2 bd alaris¿ smartsite¿ extension sets clogged at the filter during the docetaxel infusion.The following information was provided by the initial reporter: "we currently infuse multiple medications through this extension set.We've never had any issues up until last week on (b)(6) 23 when we started a new patient on a tchp regimen.During the docetaxel infusion we kept having line occlusion warnings on our bd alaris infusion pump.It appeared the medication kept clogging the filter.The docetaxel was mixed at proper concentration and as previously stated we've never had this kind of problem before.Was the tubing set attached to a patient at the time of the event or occurred during preparation/priming? attached to the patient.Was the tubing still coiled with tape in place during priming/flushing? no.How much fluid is in the drip chamber prior to priming the rest of the set? i don't know an exact amount but would assume ¾ full.Could you please advise if the filter partially or completely clogged? partially.What steps do you take to help when you do not see flow? massage tubing, squeeze infusion bag, other technique? trace the line from the bag to the patient ensuring the line is free of any clamps or kinks.Which one of these, if any, helps the fluid flow.In this case, none as the line was found to be free flowing and open.".

• Brand Name: BD ALARIS¿ SMARTSITE¿ EXTENSION 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 ; 8448235433
• MDR Report Key: 16772950
• MDR Text Key: 313946659
• Report Number: 9616066-2023-00727
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234859
• UDI-Public: 10885403234859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• 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: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 20027E
• Device Lot Number: 22099443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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