PROSORBA COLUMN 9798701

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2006-06-15 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.

Event Text Entries

[494176] Ra pt admitted to hosp the evening after her 4th prosorba treatment with complaint of severe chest pain, substernal radiating down back, headache and earache. She was hypertensive with pulse 135 and mildly febrile on admission. D dimers were elevated and she was anemic. Ct scan, echo and stress tests were negative for pe and mi. Symptoms resolved and she was discharged after 3 days. Hematology consult performed after the event suggested she might have had a reaction to the citrate or heparin used during the procedure and for maintenance of central venous catheter patency. No further prosorba. Fresenius unable to obtain discharge summary from hosp.
Patient Sequence No: 1, Text Type: D, B5


[7785248] This investigation is a clinical investigation only. Return of product not requested as evaluation of device after use not relevant to reported event. The device was used according to labeled indications and in the appropriate environment. Temporal relationship of the event and prosorba might suggest a contributory relationship.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3032792-2006-00006
MDR Report Key727490
Report Source01,05
Date Received2006-06-15
Date of Report2006-06-15
Date of Event2006-05-05
Report Date2006-06-15
Date Mfgr Received2006-05-16
Device Manufacturer Date2005-04-01
Date Added to Maude2006-06-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJOSHUA LASKER
Manufacturer Street14715 NE 95TH ST. SUITE 100
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal98052
Manufacturer Phone4252422154
Manufacturer G1FRESENIUS HEMOCARE
Manufacturer Street14715 NE 95TH ST
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal Code98052
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROSORBA COLUMN
Generic NameIMMUNOADSORPTION COLUMN
Product CodeLQQ
Date Received2006-06-15
Model Number9798701
Catalog Number9798701
Lot NumberRDN001E
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age11 MO
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key715863
ManufacturerFRESENIUS HEMOCARE
Manufacturer Address* REDMOND WA * US
Baseline Brand NamePROSORBA COLUMN
Baseline Generic NameTHERAPEUTIC PLASMA EXCHA
Baseline Catalog No9798701
Baseline Device FamilyPROTEIN A IMMUNOADSORPTION COL
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]12
Baseline PMA FlagY
Premarket ApprovalP8500
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2006-06-15

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