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U.S. Department of Health and Human Services

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

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GAMBRO DASCO SPA PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand NamePHOENIX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO DASCO SPA
one baxter parkway
deerfield IL 60015
MDR Report Key11265493
MDR Text Key229867331
Report Number11265493
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
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 Received02/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPHOENIX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/16/2020
Event Location Hospital
Date Report to Manufacturer02/02/2021
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

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