MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-03-29 for LIFECELL TISSUE CULTURE BAG 1000ML R4R9632 manufactured by Baxter Healthcare Corp..
[401995]
Received report from senior researcher at facility in 03/2005 of lifecell bag that "broke" during transplant procedure in 2005. Patient was receiving transplant of islet cells (solution) and there was a loss of approximately 15-20ml of product, but patient received the remaining amount in the bag. There was not more than 250ml of product in the bag. There is no available patient information or patient status, but the initial report denied any patient injury or medical intervention required as a result of this event. There was no testing done on the bag and reporter did not know of testing done on the patient. Procedure was performed in the operating room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000001-2005-00745 |
| MDR Report Key | 588039 |
| Report Source | 05,06 |
| Date Received | 2005-03-29 |
| Date of Report | 2005-03-08 |
| Date of Event | 2005-03-06 |
| Date Mfgr Received | 2005-03-08 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2005-04-06 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JENNY BAETHKE, MANAGER |
| Manufacturer Street | ROUTE 120 & WILSON ROAD |
| Manufacturer City | ROUND LAKE IL 60003 |
| Manufacturer Country | US |
| Manufacturer Postal | 60003 |
| Manufacturer Phone | 8472706496 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | * |
| Manufacturer City | MOUNTAIN HOME AR 72653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFECELL TISSUE CULTURE BAG 1000ML |
| Generic Name | LIFECELL BAGS |
| Product Code | KJF |
| Date Received | 2005-03-29 |
| Model Number | NA |
| Catalog Number | R4R9632 |
| Lot Number | H02F24146 |
| ID Number | NA |
| Device Expiration Date | 2004-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 577881 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | 1900 HIGHWAY NORTH MOUNTAIN HOME AR 72653 US |
| Baseline Brand Name | LIFECELL TISSUE CULTURE BAG 1000ML |
| Baseline Generic Name | LIFECELL BAGS |
| Baseline Model No | NA |
| Baseline Catalog No | R4R9632 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-29 |