MAUDE Adverse Event Report: GAMBRO PRISMAFLEX; DIALYZER, HIGH PERMEABILITY, DIALYSATE SYSTEM

Lot Number 18K2101

Device Problem Gas/Air Leak (2946)

Patient Problems Air Embolism (1697); Death (1802); Cognitive Changes (2551); Lethargy (2560)

Event Date 07/07/2019

Event Type  Death  

Event Description

Female patient with autoimmune (b)(6), s/p liver transplant, and crest syndrome was a transfer from another hospital for shortness of breath, recurrent pleural effusions, and edema.Patient developed respiratory failure and was intubated.Continuous renal replacement therapy (crrt) was also initiated.Tracheostomy was placed a few weeks later.Tunneled hemodialysis catheter was placed and exchange of right neck central venous catheter four days after tracheostomy.Patient was alert and communicative during entire admission.Twenty-five days after patient transfer (in the morning), the mental status of patient noted to be changed.Nursing noted air bubbles coming out of both the hemodialysis catheter and the central venous catheter.Ct demonstrated air emboli in right atrium, pulmonary vasculature, and diffuse hypodensity in the left hemisphere with a 3 mm rightward shift.Patient was removed from life sustaining measures and expired.The rn had put up a new filter at around 10 because of air in the line and at that time was unable to return the blood.She had the same issue again at approximately 1130 with air in the filter.All her dialysate and replacement bags were securely connected, all pins were snapped and nothing was pulling air that we could tell outright.The air was coming from the access line (the patient).When the rn flushed the hd line and drew back she didn't encounter any resistance but noticed there were a ton of small air bubbles in the syringe (1-2 ml).We changed the caps thinking there could be a crack in the connector, but the same thing happened with pulling back the air bubbles so we tried again connecting directly to the catheter without a cap, but still the same thing was happening with the air present.The bedside rn also noted air bubbles present when drawing back from the patient's triple lumen central line.As this was occurring the patient became increasingly lethargic and less responsive, and was guppy breathing on the ventilator.Pulmonary was rounding on the patient at that time and placed orders for abg and stat cts of the head and chest.Ct of the brain revealed left hemisphere infarct with a 3 mm shift.Ct of the chest revealed air in the right atrium and pulmonary artery.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY, DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO; one baxter parkway; deerfield IL 60015
• MDR Report Key: 8925691
• MDR Text Key: 155371788
• Report Number: 8925691
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/09/2019,07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 18K2101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2019
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 17885 DA