MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-04-27 for PLASMAFLO OP OP-05W manufactured by Asahi Kasei Medical Co., Ltd..
[43712958]
The product in complaint was not returned to the manufacturer and could not be analyzed. The lot number in complaint was not reported and we could not review the manufacturing and quality control records. Hypotension is listed in ifu as the event to monitor during the treatment. This ae might occurred in part or in total related to the patient's physiology. Plasmaflo op is used as plasma separator and immusorba ph is used for immunoadsorption column for separated plasma. This incident occurred in (b)(6) and is reported to fda according to the requirement.
Patient Sequence No: 1, Text Type: N, H10
[43712959]
The female patient experienced the following adverse event in (b)(6). (b)(6) 2016 10:20 the patient was started the treatment of the immunoadsorption plasmapheresis (iapp) with the plasma separator (plasmaflo op). After 15 minutes the treatment started, her blood pressure decreased from 123 mmhg to 60 mmhg. The treatment of iapp was stopped, and she was given the treatment with the normal saline solution 150ml intravenously. She was treated with the solu-cortef injection (1 ampule), then her blood pressure recovered to 130mmhg. After 15 minutes from the discontinuation of the treatment, the treatment of iapp was restarted again, then her blood pressure decreased from 130mmhg to 60mmhg. The treatment of iapp was stopped, and then the patient restarted the treatment of iapp along with an ampule (20ml) of nor-adrenalin injection at a dose of 2 ml/hr. Her blood pressure became stable. The plasma flow rate was changed from 20 ml/min to 15ml/min. Afterward her blood pressure remained around 90 mmhg during the treatment, up to the 2000 ml of plasma was treated. 13:10 her treatment was finished, her blood returned, and she left the treatment room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2016-00020 |
| MDR Report Key | 5610788 |
| Report Source | FOREIGN |
| Date Received | 2016-04-27 |
| Date of Report | 2016-03-07 |
| Date of Event | 2016-03-01 |
| Date Mfgr Received | 2016-03-07 |
| Date Added to Maude | 2016-04-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. KAORU FURUYA |
| Manufacturer Street | 1-105, KANDA, JINBOCHO, CHIYODA-KU, |
| Manufacturer City | TOKYO, 101-8101 |
| Manufacturer Country | JA |
| Manufacturer Postal | 101-8101 |
| Manufacturer G1 | ASAHI KASEI MEDICAL MT CORP. |
| Manufacturer Street | 2111-2 OAZA SATO, |
| Manufacturer City | OITA, OITA PREFECTURE 870-0396 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 870-0396 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASMAFLO OP |
| Generic Name | PLASMA SEPARATOR |
| Product Code | MDP |
| Date Received | 2016-04-27 |
| Model Number | PLASMAFLO OP |
| Catalog Number | OP-05W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2016-04-27 |