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Adverse Event Report

ERIKA DE REYNOSA FRESENIUS ARTERIAL LINE   back to search results
Model Number ARTERIAL LINE WITH PILLOW
Event Date 09/17/1997
Patient Outcome  Hospitalization;
Event Description

Pt hemolysed, determination was: suspected kinked line (unnoted during treatment) due to decrease in venous pressure and end of treatment and diagnosed with hemolytic induced pancreatitis.

 
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Brand NameFRESENIUS
Type of DeviceARTERIAL LINE
Baseline Brand NameARTERIAL LINE W/PILLOW NO HEP LINE
Baseline Generic NameARTERIAL REUSE BLOODLINE
Other Baseline ID Number9608
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ERIKA DE REYNOSA
brecha 99 parque industrial
c d reynosa
MEXICO
Manufacturer (Section D)
FRESENIUS MEDICAL CARE
22 paris ave
rockleigh NJ 07647 2696
Device Event Key121619
MDR Report Key124215
Event Key116782
Report Number124215
Device Sequence Number1
Product CodeFJK
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/01/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberARTERIAL LINE WITH PILLOW
Device Catalogue Number03-9608-5
Device LOT NumberR7E061
OTHER Device ID NumberUSE #4
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/03/1997
Distributor Facility Aware Date09/29/1997
Event Location Other
Date Report TO Manufacturer10/03/1997
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 10/03/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MED WATCH FORM DONE ON DIALYZER ALSO,

Database last updated on January 30, 2009

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