MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2002-08-29 for HEMATRON III FDR4360 manufactured by Conroy Medical Ab.
[248657]
It was reported to baxter that a hematron iii was the source of enterobacteria contamination in platelet units and 2 sample segments. The platelets had been infused in an unk number of pts who were subsequently treated for septic shock. The center tested for the bacteria in all the lab equipment and found the same organism that infected the pts on the hematron iii. It was found on no other lab equipment. The reporting hospital made assumption that the hematron iii was the source of the contaminant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420141-2002-00051 |
| MDR Report Key | 414545 |
| Report Source | 01,05 |
| Date Received | 2002-08-29 |
| Date of Report | 2002-07-31 |
| Date of Event | 2002-07-13 |
| Date Mfgr Received | 2002-07-31 |
| Date Added to Maude | 2002-09-06 |
| 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 | DEBBIE LAHR - MANAGER |
| Manufacturer Street | RT 120 & WILSON ROAD |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704695 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMATRON III |
| Generic Name | SEALER |
| Product Code | KSD |
| Date Received | 2002-08-29 |
| Model Number | NA |
| Catalog Number | FDR4360 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 403584 |
| Manufacturer | CONROY MEDICAL AB |
| Manufacturer Address | VALHALLAVAGAN 1 UPPL VASBY * S-194 63 |
| Baseline Brand Name | SEALER |
| Baseline Generic Name | HANDYSEAL |
| Baseline Model No | NA |
| Baseline Catalog No | FDR4360 |
| Baseline ID | NA |
| Baseline Device Family | SEALER |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-08-29 |