MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-03 for TAYLOR-WHARTON K SERIES * manufactured by Taylor-wharton.
[15034278]
Sometime in august/september 1995, condensation built up inside the freezer causing the lid to be frozen in place above the normal position. Consequently the lid was replaced. In march 1997, the lid replacement began to show signs of lifting with accumulated ice build-up. A new freezer was ordered and transfer of bone marrow product initiated on 5-9-97. During the process of transferring product to the new freezer it was noted that some of the product bags had leaked and now contained liquid nitrogen. During month of april 1997, freezer alarm would go off indicating need for more liquid nitrogen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 109526 |
| MDR Report Key | 109526 |
| Date Received | 1997-07-03 |
| Date of Report | 1997-05-30 |
| Date of Event | 1995-01-01 |
| Date Facility Aware | 1997-05-12 |
| Report Date | 1997-05-30 |
| Date Reported to Mfgr | 1997-06-02 |
| Date Added to Maude | 1997-08-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAYLOR-WHARTON |
| Generic Name | LIQUID NITROGEN STORAGE FREEZER |
| Product Code | JRM |
| Date Received | 1997-07-03 |
| Model Number | K SERIES |
| Catalog Number | * |
| Lot Number | * |
| ID Number | PART # 17K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 107655 |
| Manufacturer | TAYLOR-WHARTON |
| Manufacturer Address | 1505 N MAIN ST INDIANPOLIS IN 46224 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-03 |