MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 1998-04-18 for LIPOSORBER LA-15 LDL ADSORPTION COLUMN KACLA15 manufactured by Kaneka Corp.
[84270]
After treatment of 600 ml plasma using futhan as an anticoagulant, the pt's face became pale, and pt went into shock. Further, pt's blood flow from venous access was insufficient. As a result, the treatment was discontinued prematurely. According to the treating physician, this pt had not taken ace-inhibitors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435151-1998-00006 |
| MDR Report Key | 163514 |
| Report Source | 01,06 |
| Date Received | 1998-04-18 |
| Date of Report | 1998-02-17 |
| Date of Event | 1998-02-17 |
| Date Mfgr Received | 1998-02-17 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 1998-04-22 |
| 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 | 3 |
| 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 | 1998-04-18 |
| Model Number | LIPOSORBER LA-15 |
| Catalog Number | KACLA15 |
| Lot Number | LAP533 |
| ID Number | NA |
| Device Expiration Date | 2000-10-01 |
| 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 | 159176 |
| Manufacturer | KANEKA CORP |
| Manufacturer Address | 3-2-4, NAKANOSHIMA KITA-KU OSAKA JA 5308288 |
| Baseline Brand Name | LIPOSORBER LA-15 SYSTEM |
| Baseline Generic Name | LDL ADSORPTION SYSTEM |
| Baseline Model No | LIPOSORBER LA-1 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-04-18 |