MAUDE Adverse Event Report: BD BD CONNECTA PLUS STOPCOCK; STOPCOCK, I.V. SET

Model Number 394910

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 07/22/2019

Event Type  malfunction  

Event Description

Staff description: pt became disconnected from return port of continuous renal replacement therapy (crrt) and was pumping blood into the bed.No alarms went off on circuit.Disconnection was noted when blood pressure dropped.Crrt was stopped and lines were clamped.There appeared to be several hundred ml of blood in the bed.Blood pressure stabilized with increased pressors and stopping of crrt.Machine brought to clinical technology for evaluation.Sent log file to manufacturer for review.Verified parameters.Prime and alarms tests - passed.Mock treatment.Triggered venous high pressure to test audible alarm - audible alarm occurred.Machine appears to be working per specifications.According to the machine log, the venous return pressure was around 90mmhg just prior to the disconnect.Pressure then dropped to around 36mmhg.Alarm limit was set at 20mmhg.Blood flow rate was 200ml/min.Blood loss estimate was around 1000ml.A key factor appears to be the use of the tego port and the 3-way stopcock on the venous return line.The stopcock was a newly introduced model and may be more prone to not locking properly on the threads.The line disconnected where the stopcock was attached to the tego port.Another factor is the small bore of the stopcock and tego connector provided enough back pressure to prevent the low pressure alarm from triggering.Manufacturer response for dialysis machine, (brand not provided), (per site reporter).Manufacturer reviewed machine logs and suggested ways to change the alarm settings to reduce chances of failing to alarm for a line disconnect.

• Brand Name: BD CONNECTA PLUS STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BD; 5859 farinon dr ste 200; san antonio TX 78249
• MDR Report Key: 9109362
• MDR Text Key: 159799568
• Report Number: 9109362
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 394910
• Device Catalogue Number: 394910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2019
• Device Age: 0 YR
• Date Report to Manufacturer: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8030 DA