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Adverse Event Report

DIDECO, SPA AUTOTRANSFUSION SYSTEM AUTOTRANSFUSION AND APPARATUS   back to search results
Model Number COMPTADV41
Event Date 07/16/1998
Event Type  Malfunction   Patient Outcome  Required Intervention;
Event Description

It was reported that during the use of a compact advanced autotransfusion system an error message appeared. The clinician manipulated the circuit such that the surgeon would not allow the washed blood to be returned to the pt due to her religious restrictions (jehovahs witness). The pt was not injured.

 
Manufacturer Narrative

H. 3 - system was repaired in the field. H. 6. - a sorin field service technician evaluated the machine and confirmed error message. He found the reason to be a loose cap on the brush on motor, which allowed the brush to move out of position. The motor will work when the brush is out of the correct position. The system was repaired.

 
Search Alerts/Recalls

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Brand NameAUTOTRANSFUSION SYSTEM
Type of DeviceAUTOTRANSFUSION AND APPARATUS
Baseline Brand NameAUTOTRANSFUSION SYSTEM
Baseline Generic NameAUTOTRANSFUSION & APPARATUS
Baseline Catalogue NumberCOMPTADV41
Baseline Model NumberCOMPTADV41
Other Baseline ID NumberDP71-1200-006
Baseline Device FamilyAUTOTRANSFUSION SYSTEM
Baseline Device 510(K) NumberK963759
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Manufacturer (Section F)
DIDECO, SPA
via statale 12, nord 86
po box 87
mirandola (mo)
ITALY
Manufacturer (Section D)
DIDECO, SPA
via statale 12, nord 86
po box 87
mirandola (mo)
ITALY
Manufacturer (Section G)
SORIN BIOMEDICAL, INC.
17600 gillette ave.
p.o. box 19503
irvine CA 92614 5751
Manufacturer Contact
dianne knitter
17600 gillette avenue
irvine , CA 92614
(949) 250 -8329
Device Event Key176046
MDR Report Key181037
Event Key170193
Report Number2022323-1998-00023
Device Sequence Number1
Product CodeCAC
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 08/07/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberCOMPTADV41
Device Catalogue NumberCOMPTADV41
OTHER Device ID NumberDP71-1200-006
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/07/1998
Distributor Facility Aware Date07/16/1998
Event Location Hospital
Date Report TO Manufacturer07/17/1998
Date Manufacturer Received07/17/1998
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on January 30, 2009

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