CAPTURE-R READY-SCREEN (I AND II) NO MODEL NO PRODUCT CODE 5042, 5047

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2001-04-02 for CAPTURE-R READY-SCREEN (I AND II) NO MODEL NO PRODUCT CODE 5042, 5047 manufactured by Immucor, Inc..

Event Text Entries

[22079134] Capture-r ready-screen is used in place of the igg crossmatch for recipient pts without antibiotics. The pt's sample was screened with capture-r ready-screen, lot x29, and found negative. The pt was transfused with 100ml of fy (a+) red cells and developed symptoms of a severe transfusion reaction, including renal failure. Th pt had since recovered. Postransfusion investigation showed the presence of an anti-fya. This antibody was missed by lot x29 but was detected by another lot of capture-r ready-screen. Had the antibody been detected during pretransfusion testing, the incompatible unit of blood would have been excluded from use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1034569-2001-00001
MDR Report Key324014
Report Source04,05,06
Date Received2001-04-02
Date of Report2001-03-29
Date of Event2001-03-22
Date Mfgr Received2001-03-22
Device Manufacturer Date2001-02-01
Date Added to Maude2001-04-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactSUSAN ROLIH
Manufacturer Street3130 GATEWAY DR
Manufacturer CityNORCROSS GA 30071
Manufacturer CountryUS
Manufacturer Postal30071
Manufacturer Phone7704412051
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAPTURE-R READY-SCREEN (I AND II)
Generic NameIVDD REAGENT RED BLOOD CELLS
Product CodeKTO
Date Received2001-04-02
Model NumberNO MODEL NO
Catalog NumberPRODUCT CODE 5042, 5047
Lot NumberNA
ID NumberNA
Device Expiration Date2001-03-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key313484
ManufacturerIMMUCOR, INC.
Manufacturer Address3130 GATEWAY DR. NORCROSS GA 30071 US
Baseline Brand NameCAPTURE-R READY-SCREEN (I AND II)
Baseline Generic NameIVDD REAGENT RED BLOOD CELLS
Baseline Model NoNO MODEL NO
Baseline Catalog NoPRODUCT CODE 5042, 5047
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2001-04-02

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