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..
[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
Report Number | 1034569-2001-00001 |
MDR Report Key | 324014 |
Report Source | 04,05,06 |
Date Received | 2001-04-02 |
Date of Report | 2001-03-29 |
Date of Event | 2001-03-22 |
Date Mfgr Received | 2001-03-22 |
Device Manufacturer Date | 2001-02-01 |
Date Added to Maude | 2001-04-05 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Manufacturer Contact | SUSAN ROLIH |
Manufacturer Street | 3130 GATEWAY DR |
Manufacturer City | NORCROSS GA 30071 |
Manufacturer Country | US |
Manufacturer Postal | 30071 |
Manufacturer Phone | 7704412051 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Remedial Action | RC |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CAPTURE-R READY-SCREEN (I AND II) |
Generic Name | IVDD REAGENT RED BLOOD CELLS |
Product Code | KTO |
Date Received | 2001-04-02 |
Model Number | NO MODEL NO |
Catalog Number | PRODUCT CODE 5042, 5047 |
Lot Number | NA |
ID Number | NA |
Device Expiration Date | 2001-03-30 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 313484 |
Manufacturer | IMMUCOR, INC. |
Manufacturer Address | 3130 GATEWAY DR. NORCROSS GA 30071 US |
Baseline Brand Name | CAPTURE-R READY-SCREEN (I AND II) |
Baseline Generic Name | IVDD REAGENT RED BLOOD CELLS |
Baseline Model No | NO MODEL NO |
Baseline Catalog No | PRODUCT CODE 5042, 5047 |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Life Threatening | 2001-04-02 |