• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GAMBRO DASCO PRISMA CONTROL UNIT INTENSIVE CARE HEMODIALYSIS Back to Search Results
Model Number PRISMA
Device Problem Coagulation in device or device ingredient
Event Date 06/13/2007
Event Type  Other  
Event Description

The customer reported that there was a clotting in the set and that this clotting extended all the way to the pt's catheter. The machine did not alarm that there was a clotting. Facility's acute mgr described the clotting as "very unusual" in that the red blood cells and plasma appeared to have separated. She then set-up a new set and resumed treatment on this pt without difficulty. She did not think that this was a machine problem as the pt continues to receive treatment on the same prisma machine without further incident.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key979316
Report Number2087532-2007-00151
Device Sequence Number1
Product CodeKDI
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/15/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2007
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberPRISMA
Device Catalogue Number018080001
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/15/2007
Device Age8 yr
Event Location Hospital
Date Report TO Manufacturer06/15/2007
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/13/2007 Patient Sequence Number: 1
-
-