MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-11-18 for LIPOSORBER LA-15 SYSTEM MA-01 * manufactured by Kaneka Corporation.
[278167]
Patient had received 17,000 units of heparin rather than intended dose of 6,000 units during a regularly-scheduled plasmapheresis treatment. The 20ml. Syringe was completely empty at approximately 25-30 minutes into the treatment. Approximately 15ml. Should have been in the syringe. " through a subsequent visual inspection and operation of the device involved in the occurrence, the manufacturer has confirmed that the device is functioning properly. Based upon communications with the staff of the user facility, the manufacturer has concluded that the heparin syringe plunger was not properly placed into the motorized holder. Consequently, the entire contents of the syringe were drawn from it during the first 20-30 minutes of treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2002-00002 |
| MDR Report Key | 428982 |
| Report Source | 05,06 |
| Date Received | 2002-11-18 |
| Date of Report | 2002-11-18 |
| Date of Event | 2002-08-16 |
| Date Mfgr Received | 2002-10-17 |
| Device Manufacturer Date | 1997-08-01 |
| Date Added to Maude | 2002-11-25 |
| 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 |
| Manufacturer Street | 546 FIFTH AVENUE 21ST FLOOR |
| Manufacturer City | NEW YORK NY 10036 |
| Manufacturer Country | US |
| Manufacturer Postal | 10036 |
| Manufacturer Phone | 2127054340 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 SYSTEM |
| Generic Name | 1 LDL-APHERESIS SYSTEM |
| Product Code | MMY |
| Date Received | 2002-11-18 |
| Model Number | MA-01 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| 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 | 417999 |
| Manufacturer | KANEKA CORPORATION |
| Manufacturer Address | 3-2-4, NAKANOSHIMA, KITA-KU OSAKA JA 530-8288 |
| Baseline Brand Name | LIPOSORBER LA-15 SYSTEM |
| Baseline Generic Name | I LDL-APHERESIS SYSTEM |
| Baseline Model No | MA-01 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2002-11-18 |