MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-08-22 for PLASMAFLO OP OP-05W(A) N/A manufactured by Asahi Kasei Medical Co., Ltd..
[117836228]
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. According to physician's comment, the patient was treated with the anticoagulant for her first time, so the relationship between anticoagulant and the event of "blood pressure decreased" cannot be ruled out, but as after definite period of time from the start of the treatment the patient developed "blood pressure decreased", so the causal relationship of adsorption column to the event is very likely. We decided to submit this case because the causal relationship between this event and the plasmaflo op could not be denied however the physician considers the causal relationship between this event and immusorba tr350 cannot be ruled out. "blood pressure decreased" is written in the package insert as the event ("hypotonia") to monitor during the treatment. This ae might have occurred in part or in total related to the patient's physiology. Plasmaflo op is used as plasma separator and immusorba tr-350 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
[117836229]
The female patient experienced the following adverse event in (b)(6). The female patient, whose blood pressure was 110mmhg, was started the treatment of the immunoadsorption plasmapheresis (iapp) with the plasma separator (plasmaflo op-05w), which was a similar product of plasmaflo op-05w(a) sold in u. S. After 75 minutes the treatment started, her blood pressure (bp) decreased to 40 mmhg rapidly. She was given the treatment of elevation of lower extremities and with the normal saline solution 500ml intravenously, and was given oxygen 4l. After 30 minutes, she was started with the treatment of the normal saline solution intravenously by her blood access. After 15 minutes her blood pressure recovered to 100mmhg, she went back to her hospital ward. This was her first time for her treatment of iapp, but after this event she was not given such treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2018-00170 |
| MDR Report Key | 7804167 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-08-22 |
| Date of Report | 2018-07-27 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2018-08-22 |
| 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 | MR. AKITAKE YAMASHITA |
| Manufacturer Street | 1-1-2 YURAKUCHO, CHIYODA-KU |
| Manufacturer City | TOKYO 100-0006 |
| Manufacturer Country | JA |
| Manufacturer Postal | 100-0006 |
| Manufacturer G1 | ASAHI KASEI MEDICAL MT CORP. |
| Manufacturer Street | OITA WORKS 2111-2 OAZA SATO |
| Manufacturer City | OITA-SHI, OITA 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 | 2018-08-22 |
| Model Number | OP-05W(A) |
| Catalog Number | N/A |
| Lot Number | N/A |
| 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 | 1-1-2 YURAKUCHO CHIYODA-KU TOKYO 100-0006 JA 100-0006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-22 |