MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-08-14 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corp..
[3604358]
During a ldl-apheresis (ldl-a) procedure with liposorber la-15 system, the pt (pt) developed a shock symptom (his blood pressure (bp) dropped to 40mmhg) when 500ml of plasma was processed. The ldl-a procedure was immediately terminated and 1,000ml of saline was given i. V. To the pt. The pt recovered and no aftereffect remains. It was the very first ldl-a procedure for the pt. The pt was prescribed with an ace-inhibitor (renivace) in the other department who was in charge of the pt, however, the info was not shared with the apheresis unit and the ldl-a was conducted under the influence of the ace-inhibitor.
Patient Sequence No: 1, Text Type: D, B5
[11063047]
Anaphylactoid reactions with severe hypotension including shock are known side effects, especially in pts who are concomittantly treated with ace-inhibitors, which are attributed to the dextran sulfate-cellulose gels or the ingredient of the device, "liposorber la-15 ldl adsorption columns". In (b)(6), pts being treated with any ace-inhibitor is contra-indicated to the ldl-apheresis with the device. In our investigation, the pt was found taking an ace-inhibitor, "renivace", which was prescribed by the other department of the same facility, and the apheresis unit conducted the ldl-apheresis with the device without aware of the fact that the pt was taking an ace-inhibitor. Accordingly, we believe that the event was caused by a user error to the device against contra-indication and not be any defect or malfunction of the device. The actual device used was not available for our further investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614654-2013-00002 |
| MDR Report Key | 3297745 |
| Report Source | 01,05 |
| Date Received | 2013-08-14 |
| Date of Report | 2013-08-07 |
| Date of Event | 2013-07-22 |
| Date Added to Maude | 2013-08-21 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MASAHARU INOUE |
| Manufacturer Street | 546 FIFTH AVE 21ST FLOOR |
| Manufacturer City | NEW YORK NY 10036 |
| Manufacturer Country | US |
| Manufacturer Postal | 10036 |
| Manufacturer Phone | 8005263522 |
| Manufacturer G1 | KANEKA CORP. |
| Manufacturer Street | 2-18-3 NAKANOSHIMA, KITA-KU |
| Manufacturer City | 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 APHERESIS SYSTEM |
| Product Code | MMY |
| Date Received | 2013-08-14 |
| Model Number | LA-15 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-08-14 |