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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DASCO PRISMA CONTROL UNIT INTENSIVE CARE HEMODIALYSIS

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GAMBRO DASCO PRISMA CONTROL UNIT INTENSIVE CARE HEMODIALYSIS Back to Search Results
Model Number PRISMA
Device Problem Pressure sensor failure
Event Date 02/23/2007
Event Type  Malfunction  
Event Description

"continuous renal replacement therapy machine transported. Unable to prime the machine using filters from two different lot numbers. Machine read "self test failure", "prime failure", and "00f0". Patient had to receive medical treatment for hyperkalemia and conventional acute hemodialysis. ".

 
Manufacturer Narrative

The patient required medical treatment for hyperkalemia and was started on convention hemodialysis. Facility's biomedical technician inspected the machine and found the reason the machine did not pass the initial self-test was a problem with reposition of the pressure pod. He ordered a new part.

 
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Brand NamePRISMA CONTROL UNIT
Type of DeviceINTENSIVE CARE HEMODIALYSIS
Manufacturer (Section D)
GAMBRO DASCO
via modenese, 66
medolla (mo) I-41 036
ITALY I-41036
Manufacturer (Section G)
GAMBRO DASCO
via modenese, 66
medolla (mo) I-41 036
ITALY I-41036
Manufacturer Contact
francesco bardelli
via modenese, 66
medolla (mo)  I-410-36
ITALY   I-41036
53550111
MDR Report Key971782
Report Number9616240-2007-00042
Device Sequence Number1
Product CodeKDI
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/02/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2007
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberPRISMA
Device Catalogue Number018080100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/02/2007
Device Age10 yr
Event Location Hospital
Date Report TO Manufacturer03/02/2007
Date Manufacturer Received03/02/2007
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/1997
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: 03/30/2007 Patient Sequence Number: 1
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