MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-23 for LIPOSORBER LA-15 KACL15 manufactured by Kaneka Corp. Medical Devices Div..
[22075411]
First ldl-apheresis procedure was conducted on 11/21/97 without problem using nafamostat mesilate as anticoagulant. After treatment pt took adalat (nifedipine) and procylin (beraprost sodium) instead of ace inhibitor. Second ldl-apheresis procedure on 11/25/97 conducted using heparin as anticoagulant. Procedure initiated at 13:30. Pt yawned at 14:00. At 14:05, pt experienced sweating and nausea (blood p: 77 mmhg; pulse rate: 58). Procedure discontinued at 14:10. Pulse rate decreased to 40, and temporary asytole occurred but recovered with tap on chest. Procedure restarted at 14:45 using nafamostat mesilate (blood p: 177 mmhg: pulse rate: 58), and procedure was completed without further problem. The next two ldl-apheresis procedures were completed without incident using nafamostat mesilate as an anticoagulant. Pt continued taking adalat and procylin. The remaining effect by ace-inhibitor may have caused or contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435151-1997-00002 |
| MDR Report Key | 140022 |
| Date Received | 1997-12-23 |
| Date of Report | 1997-12-23 |
| Date of Event | 1997-11-25 |
| Date Facility Aware | 1997-12-11 |
| Report Date | 1997-12-23 |
| Date Added to Maude | 1997-12-30 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | BIOMEDICAL ENGINEER |
| 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 | LIPOSORBER LA-15 |
| Generic Name | LDL ADSORPTION COLUMN |
| Product Code | MMY |
| Date Received | 1997-12-23 |
| Model Number | LIPOSORBER LA-15 |
| Catalog Number | KACL15 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 136703 |
| Manufacturer | KANEKA CORP. MEDICAL DEVICES DIV. |
| Manufacturer Address | 3-2-4, NAKANOSHIMA, KITA-KU OSAKA JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Life Threatening | 1997-12-23 |