MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-02-26 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corp..
[4183972]
The ldl-apheresis (ldl-a) with liposorber la-15 system was applied to a (b)(6) years of age female in-patient (pt) for the treatment of her arterio sclerosis obliterance (aso). The patient is not on chronic hemodialysis (non-hd), non-diabetic, amputated at below the knee (the right leg) and scleroderma. It was her very first experience with the ldl-a. She developed a very severe hypotension to become unconscious, cardiopulmonary arrest at around one (1) hour after starting the procedure. The procedure was immediately terminated, and cardiac massage, bosmin (adrenalin) i. V. Administration, was given to her. Her blood pressure gradually rose and she revived approximately ten (10) minutes after. However, her blood pressure dropped and her conscious level lowered again at around 20 minutes after the revival. Bosmin i. V. Was given and her blood pressure and consciousness recovered. Then, she was transferred to the icu, stayed overnight in the icu and left the icu the next day with a stable condition.
Patient Sequence No: 1, Text Type: D, B5
[11630341]
The patient is not on chronic hemodialysis (non-hd), and the event occurred in her very first experience with this sort of extracorporeal circulation therapy. We guess a possibility of vasovagal reaction or by her mental problem due to a heavy stress, uneasiness with unexperienced treatment. The patient did not take any ace-inhibitor which is contra indicated to the ldl-a in (b)(6). However, she took a calcium antagonist as a hypotensive drug, and a concomitant ldl-a with the device might result in severe hypertension than anticipated. However, the reason of her developing such a severe hypertension cannot be clarified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614654-2014-00003 |
| MDR Report Key | 3647878 |
| Report Source | 01,05 |
| Date Received | 2014-02-26 |
| Date of Report | 2014-02-19 |
| Date of Event | 2014-01-30 |
| Date Added to Maude | 2014-02-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MASAHARU INOUE |
| Manufacturer Street | 546 FIFTH AVENUE 21ST FLOOR |
| Manufacturer City | NEW YORK NY 10036 |
| Manufacturer Country | US |
| Manufacturer Postal | 10036 |
| Manufacturer Phone | 8005263522 |
| Manufacturer G1 | KANEKA CORP. |
| Manufacturer Street | 2-3-18 NAKANOSHIMA |
| Manufacturer City | KITA-KU, OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 530-8288 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 SYSTEM |
| Generic Name | LDL APHERSIS SYSTEM |
| Product Code | MMY |
| Date Received | 2014-02-26 |
| Model Number | LA-15 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORP. |
| Manufacturer Address | OSAKA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-26 |