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Adverse Event Report

DIDECO SPA D901 LILLIPUT 1 OPEN SYSTEM MEMBRANE OXYGENATOR WITH VENOUS AND CARDIOTOMY RESERVOIR   back to search results
Catalog Number 5318
Device Problems Bubble(s); Fluid leak(s)
Event Date 10/01/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The cardiotomy filter compartment filled with foam that entered the venous reservoir. Blood foam bubbled out of the reservoir vent. During the procedure approximately 400 cc of blood was lost. To compensate for this loss, blood was given. The pt's recovery was uneventful.

 
Manufacturer Narrative

H6. ) a visual inspection of the returned device was performed. It revealed that the blood loss occurred from the vent port of the cardiotomy reservoir. No visual defects were noted on the returned unit. In addition, a simulated use test of the cardiotomy filter defoamer was performed on three unused test units from the same lot as the reported failure. The results were compared to three other units (controls) from different lots. The defoaming test revealed that there was no difference in performance between the test units and the control units. All units passed dideco's requirements for defoaming performance. Dideco reviewed its manufacturing records and found the product was built correctly. Visual inspection and performance testing did not reveal any defects.

 
Search Alerts/Recalls

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Brand NameD901 LILLIPUT 1 OPEN SYSTEM
Type of DeviceMEMBRANE OXYGENATOR WITH VENOUS AND CARDIOTOMY RESERVOIR
Baseline Brand NameD901 LILLIPUT 1 OPEN SYSTEM
Baseline Generic NameMEMBRANE OXYGENATOR WITH VENOUS AND CARDIOTOMY RESERVOIR
Baseline Catalogue Number5318
Baseline Device FamilyMEMBRANE OXYGENATOR WITH VENOUS AND CARDIOTOMY RESERVOIR
Baseline Device 510(K) NumberK953835
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed08/06/1999
Manufacturer (Section F)
DIDECO SPA
via statale 12 nord, 86
mirandola (mo)
ITALY 41037
Manufacturer (Section D)
DIDECO SPA
via statale 12 nord, 86
mirandola (mo)
ITALY 41037
Manufacturer Contact
jack ellison
14401 w 65th way
arvada , CO 80004-3599
(303) 467 -6306
Device Event Key483234
MDR Report Key494523
Event Key468878
Report Number1718850-2003-00022
Device Sequence Number1
Product CodeDTZ
Report Source Manufacturer
Source Type Health Professional,User facility,Other
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 11/07/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/31/2007
Device Catalogue Number5318
Device LOT Number0303210045
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/07/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/09/2003
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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