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

Model Number 6023006700

Device Problems Unintended Ejection (1234); Material Separation (1562); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  malfunction  

Event Description

Machine #16717 (brand new machine) shut down during dialysis treatment without "general safe state" warning.Power tripped as well so unable to turn machine back on until reset.This nurse encouraged patient to finish treatment on a different machine, but patient declined offer and instead decided he wanted to be done.Rinseback given manually.Patient off approximately 150 minutes early.Biomed notified (who later notified representative who sold us the machine) and situation explained.Manufacturer response for hemodialysis unit, (per site reporter).Pulled back of unit off and discovered 90 degree elbow right above pa pump had come apart causing big leak.Replaced plastic 90 with a rubber 90 because where line came out of 90 would not lock back in.Ran rinse and patient sim without error.Called baxter and spoke with manufacturer rep and stated what i found and what i did and that there was no harm to patient other than they didn't receive full treatment.Rep gave me incident (b)(4) captured report of patient incident.I also told them the unit tripped the ground fault circuit outlet on the wall.For this reason they suggested that because unit only had 11.33 hours on it that they should send out one of their reps out to check unit out for safety second look.Field service engineer rep called me and is tentatively planning to come out following week to double check unit, they told me they would basically being doing the same thing i did.(b)(4) on site physical and functional checkout of device.They also said i could return unit to service for now and they are still going to send field service engineer next week.Will leave wo open pending field service engineer coming out to look at it and their report on unit.One day later training received on phoenix troubleshooting.3 days later (wo labor id (b)(4)) checked with field service engineer to make sure they were still coming out tomorrow, and they said due to other units actually being down in their area they wouldn't be able to make it up, they asked if we still needed it looked at and i told them yes.They then replied with someone else will be contacting me next week to set up visit.One week later (wo labor id (b)(4) ) received a call from new baxter field service engineer.Explained what happened, they seemed to think the heater got wet.They are working on a time and date to come up and look at unit.One week later (wo labor id (b)(4)) attached vendor paperwork and closed out wo.This has been a known issue with my other two biomed technicians, escalating to the fda.

• 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: 12352899
• MDR Text Key: 267715179
• Report Number: 12352899
• 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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6023006700
• Device Catalogue Number: 103453
• 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: 08/02/2021
• Date Report to Manufacturer: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1