MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 385100

Device Problems Backflow (1064); Leak/Splash (1354)

Patient Problem Loss of consciousness (2418)

Event Date 07/31/2022

Event Type  Injury  

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 the bd q-syte¿ luer access split-septum stand-alone device leaked and blood flowed backwards along the line.The patient changed the q-syte to stop the leakage, but lost consciousness the following morning and collapsed.The patient was taken to the local hospital as a result of the under dosage of epoprostenol.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "i would like to report a problem with the bd q-syte breaking during use.We have had 2 of our patients admitted to hospital over the past 24 hours due to leaking or fractured bd q-sytes used as part of their intravenous epoprostenol infusions.Epoprostenol is a potent vasodilator that is used to treat patients with pulmonary hypertension with a half-life of 3-5 minutes.Our patients are trained on how to prepare and manage their infusions and pumps as these need to run 24 hours a day 7 days a week, they cannot be interrupted as this can cause rebound vasoconstriction resulting in right heart failure and potentially cardiac arrest within 10-15 minutes.Our other patient had noticed that his line was leaking from around his bd q-syte yesterday and that blood was flowing backwards along the line, he sensibly had changed his infusion, replaced the bd q-syte and this stopped.This morning he lost consciousness and collapsed and was taken into his local hospital, this may well have been related to having less drug over the past 24 hours.".

Manufacturer Narrative

H6: investigation summary a review of the device history record was performed for the reported lot, 1118484, and no quality issues were found during production.The engineer could not make a determination as to the reported issues of leakage or back flow since no sample was returned for these incidents.

Event Description

It was reported that the end of the bd q-syte¿ luer access split-septum stand-alone device broke off while the patient was out shopping and leaked epoprostenol.The patient was unable to remove the broken end from the line and had to be taken to the local a&e in an ambulance, where she was then transferred to the hospital.Forceps were used to remove the broken piece, and a temporary line was used for the patient, who was also checked from infection due to the leakage.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "i would like to report a problem with the bd q-syte breaking during use.We have had 2 of our patients admitted to hospital over the past 24 hours due to leaking or fractured bd q-sytes used as part of their intravenous epoprostenol infusions.Epoprostenol is a potent vasodilator that is used to treat patients with pulmonary hypertension with a half-life of 3-5 minutes.Our patients are trained on how to prepare and manage their infusions and pumps as these need to run 24 hours a day 7 days a week, they cannot be interrupted as this can cause rebound vasoconstriction resulting in right heart failure and potentially cardiac arrest within 10-15 minutes.One of our patients was out shopping when she felt moisture and realised that her line was leaking and that the end had snapped off.The only think keeping everything together was the extension tubing which had split as the connector had broken.Unfortunately she could not remove the small broken end from her hickman line and ended up going to her local a&e in an emergency ambulance from which she was transferred to our hospital.It was difficult to remove and in the end we needed to use forceps hence the damage to the surface of the connector.She spent 48 hours in hospital with a temporary line whilst the problem was managed and had to be checked for infection due to several hours with the line leaking.".

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15303605
• MDR Text Key: 298764863
• Report Number: 9610847-2022-00325
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: 00382903851003
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K013621
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 385100
• Device Lot Number: 1118484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male