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 2018-11-08 for PLASMAFLO OP OP-05W(A) N/A manufactured by Asahi Kasei Medical Co., Ltd..
[126508463]
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 and causal relationship between this device and the event could not be denied because the event happened during the immunoadsorption plasmapheresis therapy. We are unable to investigate since the actual used medical device was not returned to us and the lot number was unknown. The root cause could not be identified. The adverse event may have been caused by clinical condition of the patient.
Patient Sequence No: 1, Text Type: N, H10
[126508464]
The female patient with primary disease of myasthenia gravis experienced following adverse event during immunoadsorption plasmapheresis treatment. The patient received the first immunoadsorption plasmapheresis therapy on (b)(6) 2018 and the second therapy on (b)(6) 2018 with no issue. On (b)(6) 2018, the third therapy was given to the patient. The patient blood pressure was between 110 and 120 mmhg and heart rate was 60 bpm before the therapy. 34 minutes after the therapy was started, her blood pressure was decreased to 100 mmhg. 41 minutes after the therapy was started, she complained of epigastric pain. Since the blood pressure was decreased to 58 mmhg and heart rate was also decreased to between 30 to 40 bpm, 300 ml of normal saline was administered. After the administration of normal saline, the patient blood pressure was increased to 100 mmhg temporarily, but it was decreased again to 70 mmhg and consciousness level was dropped. To treat the symptoms, oxygen therapy was administered at 1l/min. 49 minutes after the treatment was started, the blood pressure was increased to 126 mmhg and level of consciousness was recovered. The blood was returned to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2018-00200 |
| MDR Report Key | 8050026 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-08 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-10-12 |
| Date Added to Maude | 2018-11-08 |
| 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 | 2018-11-08 |
| 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. Congenital Not Applicablenomaly; 2. Hospitalization; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit | 2018-11-08 |