MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for PLASMAFLO OP OP-08W manufactured by Asahi Kasei Medical Co., Ltd..
[95451469]
This incident occurred in (b)(6) and we are reporting this event since we consider the severity of the event is serious injury as the patient experienced shock with cardiac arrest and the causal relationship between this device and the event could not be denied because the event happened during the treatment. The actual used product was not returned to us for investigation and could not be analyzed, however the lot number was reported and we are reviewing the manufacturing and quality control records. We will make additional report to fda as soon as we get the result. Analysis will be proceeded base on lot number.
Patient Sequence No: 1, Text Type: N, H10
[95451470]
During her first plasma exchange (pe), the patient went into shock with cardiac arrest 30 minutes after the connection. She was treated for a guillain barre syndrom. No other plasma exchange is planned as the patient is now treated by intravenous immunoglobulin(ivig). The patient did not suffer from aftereffects and got back home after a few hours under surveillance in the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2017-00040 |
| MDR Report Key | 7136823 |
| Date Received | 2017-12-20 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-11-30 |
| Device Manufacturer Date | 2017-02-14 |
| Date Added to Maude | 2017-12-20 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. AKITAKE YAMASHITA |
| Manufacturer Street | 1-105, KANDA JINBOCHO CHIYODA-KU |
| Manufacturer City | TOKYO, 101-8101 |
| Manufacturer Country | JA |
| Manufacturer Postal | 101-8101 |
| Manufacturer Phone | 32963735 |
| Manufacturer G1 | ASAHI KASEI MEDICAL MT CORP. |
| Manufacturer Street | OITA WORKS 2111-2 OAZA SATO, OITA-SHI |
| Manufacturer City | OITA, 870-0396 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 870-0396 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLASMAFLO OP |
| Generic Name | PLASMA SEPARATOR |
| Product Code | MDP |
| Date Received | 2017-12-20 |
| Model Number | PLASMAFLO OP |
| Catalog Number | OP-08W |
| Lot Number | FG1W2B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASAHI KASEI MEDICAL CO., LTD. |
| Manufacturer Address | 1-105, KANDA JINBOCHO CHIYODA-KU TOKYO, 101-8101 JA 101-8101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-20 |