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 2017-12-27 for PLASMAFLO OP OP-05W manufactured by Asahi Kasei Medical Co., Ltd..
[95799879]
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 treatment. The root cause could not be identified. The adverse event may have been caused by clinical condition of the patient. We are unable to investigate since the actual used medical device was not returned to us and the lot number was unknown.
Patient Sequence No: 1, Text Type: N, H10
[95799880]
In (b)(6) 2017, the patient was given the treatment with immunoadsorption plasmapheresis with plasma separator (plasmaflo op). At the beginning of the treatment, the systolic blood pressure decreased from 110 mmhg to 90 mmhg and the lower extremities were elevated for the intervention. The treatment was restarted at 15% of the plasma separator flow rate. Since the systolic blood pressure was able to maintain between 100 to 110mmhg at this flow rate for an hour, the plasma separator flow rate was increased to 18%. After 15 minutes of this increase of the flow rate, the systolic blood pressure was dropped to approximately 80mmhg. When the blood pressure was re-measured, the systolic blood pressure was between 50mmhg to 60mmhg and the heart rate was between 80bpm to 110bpm with atrial fibrillation. The treatment was discontinued and the blood was returned to the patient. The physician was called since the blood pressure did not increase as well as the heart rate was decreased to approximately between 40bpm to 50bpm with bradycardia even though normal saline 100ml via intravenous was administered. After an additional normal saline 200ml and 2ml of ephedrine 1 ample(1ml) diluted with normal saline 10ml were administered, the systolic blood pressure and the heart rate were returned to 120mmhg and 80bpm. The patient went back to the room of the admitted unit after the observation which the systolic blood pressure was recovered to 110mmhg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2017-00050 |
| MDR Report Key | 7147178 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-12-27 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-11-09 |
| Date Mfgr Received | 2017-12-07 |
| Date Added to Maude | 2017-12-27 |
| 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 | 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 | 3 |
| Brand Name | PLASMAFLO OP |
| Generic Name | PLASMA SEPARATOR |
| Product Code | MDP |
| Date Received | 2017-12-27 |
| 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. Life Threatening | 2017-12-27 |