MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03 report with the FDA on 1998-03-09 for LIPOSORBER LA-15 LDL ADSORPTION COLUMN LIPOSORBER LA-15 SYSTEM KACLA15 manufactured by Kaneka Corp..
[106340]
Dr. Reported as follows: after treatment of 2200 ml plasma, pt's systolic blood pressure dropped to 50-70 mm hg. Pt suffered from abdominal pain, bradycardia, acrimation and facial edema. Injections of steriods, sympathomimetics, as well as fluid replacement and oxygen application were unsuccessful. Immediate disconnection from the liposorber la-15 system led to normalization of blood pressure after 20 minutes. One hour later, pt felt well and was discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435151-1998-00005 |
| MDR Report Key | 154798 |
| Report Source | 01,03 |
| Date Received | 1998-03-09 |
| Date of Report | 1998-03-06 |
| Date of Event | 1997-05-01 |
| Date Mfgr Received | 1998-01-07 |
| 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 | LIPOSORBER LA-15 LDL ADSORPTION COLUMN |
| Generic Name | LDL ADSORPTION SYSTEM |
| Product Code | MMY |
| Date Received | 1998-03-09 |
| Model Number | LIPOSORBER LA-15 SYSTEM |
| Catalog Number | KACLA15 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 150793 |
| Manufacturer | KANEKA CORP. |
| Manufacturer Address | 3-2-4, NAKANOSHIMA, KITA-KU OSAKA JA 5308288 |
| Baseline Brand Name | LIPOSORBER LA-15 LDL ADSORPTION COLUMN |
| Baseline Generic Name | LDL ADSORPTION SYSTEM |
| Baseline Model No | LIPOSORBER LA-1 |
| Baseline Catalog No | KACLA15 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1998-03-09 |