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 |