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 LIPOSORBER LA-15 SYSTEM MA-01 APHERESIS MACHINE NA manufactured by Kaneka Corp.
[20200559]
Plasma did not flow into the liposorber column correctly due to loosening of clamp valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435151-1998-00001 |
| MDR Report Key | 155396 |
| Report Source | 01,07 |
| Date Received | 1998-03-09 |
| Date of Report | 1996-07-28 |
| Date of Event | 1996-07-25 |
| Date Mfgr Received | 1996-08-01 |
| Device Manufacturer Date | 1994-12-01 |
| Date Added to Maude | 1998-03-13 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 SYSTEM |
| Generic Name | MA-01 APHERESIS MACHINE |
| Product Code | MMY |
| Date Received | 1998-03-09 |
| Model Number | MA-01 APHERESIS MACHINE |
| 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 | 151370 |
| Manufacturer | KANEKA CORP |
| Manufacturer Address | 3-2-4, NAKANOSHIMA, KITA-KU OSAKA JA 5308288 |
| Baseline Brand Name | LIPOSORBER LA-15 SYSTEM |
| Baseline Generic Name | MA-01 APHERESIS MACHINE |
| Baseline Model No | MA-01 APHERESIS |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-03-09 |