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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO UF SOLUTIONS PRISMAX CONTROL UNIT DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO UF SOLUTIONS PRISMAX CONTROL UNIT DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number A6017
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Blood Loss (2597)
Event Date 04/05/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Prismax control unit was evaluated by field technical service and no product problem was found. The data log was reviewed a built in on-going test (biot) was declared for the liquid level sensor. The liquid level sensor component was returned for additional investigation.
 
Event Description
It was reported that a patient was treated with continuous renal replacement therapy (crrt). An alarm related to the low level of the degassing chamber was reported. Then without user intervention the blood level rose in the degassing chamber and return pressure line. The blood reached the blood catcher of the return line. A system failure alarm was then triggered by the monitor. The treatment was discontinued without blood restitution and the patient blood loss was estimated to 189 ml. The patient did not present with clinical symptoms; however, the patient reportedly had a blood transfusion following the blood loss. No additional information is available.
 
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Brand NamePRISMAX CONTROL UNIT
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO UF SOLUTIONS
7601 northland drive
suite 170
brooklyn park MN
Manufacturer (Section G)
GAMBRO UF SOLUTIONS
7601 northland drive
suite 170
brooklyn park MN 55428
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6553360
MDR Text Key74697815
Report Number3003504604-2017-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K163530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberA6017
Device Catalogue Number115369
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/09/2017 Patient Sequence Number: 1
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