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Adverse Event Report

DIDECO SPA LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR W/HARDSHELL RESERV PEDIATRIC MEMBRANE OXYGENATOR   back to search results
Model Number PEDIATRIC MEMBRANE OXYGENATOR
Device Problems Deliver, failure to; Device failure
Event Date 03/31/1999
Patient Outcome  Required Intervention;
Event Description

It was reported that during a bypass procedure, the monolyth oxygenator exhibited low po2 readings. The oxygenator was changed out with another monolyth oxygenator and the procedure continued without further incident. There was no pt injury.

 
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Brand NameLILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR W/HARDSHELL RESERV
Type of DevicePEDIATRIC MEMBRANE OXYGENATOR
Baseline Brand NameLILLIPUT NEWBORN HOLLOW FIBER OXYGENATOR MODULE W/O BAG
Baseline Generic NameLILLIPUT 2 OXYGENATOR
Baseline Catalogue Number5316
Baseline Model NumberPEDIATRIC MEMBRANE OXYGENATOR
Other Baseline ID NumberDP34-1143-102
Baseline Device FamilyPEDIATRIC MEMBRANE OXYGENATOR
Baseline Device 510(K) NumberK971877
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed10/01/1997
Manufacturer (Section D)
DIDECO SPA
via statale 12 nord 86
mirandola (mo)
ITALY 41037
Device Event Key218225
MDR Report Key225047
Event Key211209
Report Number225047
Device Sequence Number1
Product CodeDTZ
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/21/1999,04/30/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberPEDIATRIC MEMBRANE OXYGENATOR
Device Catalogue Number5324
OTHER Device ID NumberDP34-1154-101
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/1999
Distributor Facility Aware Date03/31/1999
Event Location Hospital
Date Report TO Manufacturer03/31/1999
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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