MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1998-03-09 for TUBING SYSTEM FOR PLASMAPHERESIS LT-MA2 NA manufactured by Kaneka Corp..
[88323]
At the beginning of the treatment, leakage of plasma occurred at the connection of the tubing set. The pt became sick and went into shock. The physician determined that a hypovolemia due to the loss of plasma was the cause of the shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435151-1998-00003 |
| MDR Report Key | 154784 |
| Report Source | 01,07 |
| Date Received | 1998-03-09 |
| Date of Report | 1997-08-27 |
| Date of Event | 1997-08-13 |
| Date Mfgr Received | 1997-09-18 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 1998-03-11 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUBING SYSTEM FOR PLASMAPHERESIS LT-MA2 |
| Generic Name | TUBING SET |
| Product Code | MMY |
| Date Received | 1998-03-09 |
| Model Number | LT-MA2 |
| Catalog Number | NA |
| 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 | 150779 |
| Manufacturer | KANEKA CORP. |
| Manufacturer Address | 3-2-4, NAKANOSHIMA, KITA-KU OSAKA JA 5308288 |
| Baseline Brand Name | LIPOSORBER LA-15 SYSTEM |
| Baseline Generic Name | TUBING SET |
| Baseline Model No | LT-MA2 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1998-03-09 |