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

Catalog Number 10839681

Device Problems Backflow (1064); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd smallbore trifuse extension set blood backflowed during infusion.There was no report of patient impact.The following information was provided by the initial reporter: our adult micu experienced issues with bd smallbore extension set, ref: 10839681.The feedback below came from nursing staff: patient received on same dose of levo and vaso running through triflo lumen.Doses were not changed, but midshift, patient's bp was 70s/40s, primary rn going up on levo and vaso, but patient bp was not responding.Primary rn noticed that patient's gown was wet and noticed that the medication was leaking through one of the lumens on the triflo that was not connected to a medication.Of note, that lumen was not clamped.Primary rn clamped lumen, resuscitated with ns bolus (as per order) and was able to come down on the pressor doses to baseline.Previously we were using different triflows that seemed to have worked fine (icu medical mx458l), but i have heard from several rns that reported medication and even blood would back up into this triflo (bd 10839681).This would happen when no medication was running and during a kvo infusion that was running at 3ml/hour.In both of these instances, a nav was attached between the iv tubing and the triflo.These issues were not experienced with the former product, even when lumens were unclamped while not in use.

Manufacturer Narrative

H.6.Investigation summary: no product or photo was returned by the customer.The customer complaint of flow issues (backflow) could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.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.H3 other text : see h10.

Event Description

It was reported while using bd smallbore trifuse extension set blood backflowed during infusion.There was no report of patient impact.The following information was provided by the initial reporter: our adult micu experienced issues with bd smallbore extension set, ref: (b)(4).The feedback below came from nursing staff: patient received on same dose of levo and vaso running through triflo lumen.Doses were not changed, but midshift, patient's bp was 70s/40s, primary rn going up on levo and vaso, but patient bp was not responding.Primary rn noticed that patient's gown was wet and noticed that the medication was leaking through one of the lumens on the triflo that was not connected to a medication.Of note, that lumen was not clamped.Primary rn clamped lumen, resuscitated with ns bolus (as per order) and was able to come down on the pressor doses to baseline.Previously we were using different triflows that seemed to have worked fine (icu medical mx458l), but i have heard from several rns that reported medication and even blood would back up into this triflo (bd 10839681).This would happen when no medication was running and during a kvo infusion that was running at 3ml/hour.In both of these instances, a nav was attached between the iv tubing and the triflo.These issues were not experienced with the former product, even when lumens were unclamped while not in use.

• Brand Name: BD SMALLBORE TRIFUSE 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17687636
• MDR Text Key: 323167196
• Report Number: 9616066-2023-01849
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234536
• UDI-Public: (01)50885403234536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

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: Other
• Device Catalogue Number: 10839681
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/01/2023
• 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