MAUDE Adverse Event Report: GAMBRO DASCO SPA PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number PHOENIX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss Of Pulse (2562)

Event Date 12/09/2020

Event Type  malfunction  

Event Description

Pt having dialysis run in. In pt dialysis, lost pulse and code blue called. Pt coded intubated and transferred to icu. Manufacturer response for hemodialysis unit, gambro (per site reporter): when the unit came down to the shop. I ran a setup with a pa and puf auto cal. Performed a patient simulation for 30 minutes. Unit passed. Total amount removed according to unit: 800 ml-- measured amount 807. 9 ml (within 25ml +/-). While the patient simulation passed without any errors/alarms. I found a leak on the bic conductivity. The leak was approximately 3 drops a minute. Once the patient simulation was completed. I proceeded to go through all of the tests that are required for an annual inspection. The unit passed every test with no discrepancies being noted. Once complete i discussed all of my findings/readings of the unit with baxter tech support. We had discussed having baxter tech support come to the hospital to possibly inspect the unit. But because i am certified on the unit and did not believe the unit was the cause of the incident and because the patient was only on the unit for a total of 4 minutes and passed all operational tests they stated that they did not need to come out. After getting the go ahead from baxter, i replaced both the ace and bic conductivity cells and also the safety valve. After all the components were installed. I ran a setup with a pa and puf auto cal. Performed a patient simulation for 30 minutes. Unit passed. Total amount removed according to unit: 800 ml-- measured amount 803. 4 ml (within 25ml +/-) completed a bleach/rinse. Unit returned to service.

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO DASCO SPA; one baxter parkway; deerfield IL 60015
• MDR Report Key: 11265493
• MDR Text Key: 229867331
• Report Number: 11265493
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2020,12/10/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PHOENIX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown