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 2019-03-04 for PLASMAFLO OP OP-05W(A) N/A manufactured by Asahi Kasei Medical Co., Ltd..
[137654688]
This incident occurred in (b)(6) and is reported to fda according to the requirement. Plasmaflo op-08w is similar product of plasmaflo op-05w(a) marketed in us. The used product and information of lot number were not available because the product was disposed in the healthcare facility. Consequently, the root cause of the event could not be identified as only the insufficient information was available. Plasmaflo op is used as plasma separator and plasma component is further separated by plasorba brs, which was concomitantly used for the patients. Pulmonary alveolar hemorrhage which caused the patient's death is not described in the instructions for use (ifu) of plasmaflo op. Physician considered that this patient's death was mainly caused by the aggravation of patient's complication of serious liver failure, pulmonary alveolar haemorrhage. However, since the adverse event occurred during the treatment, the causal relationship between the patient's pulmonary alveolar haemorrhage and plasmaflo op could not be denied. We considered that the pulmonary alveolar haemorrhage was serious, and that the causal relationship between plasmaflo op and the pulmonary alveolar haemorrhaget could not be denied because the adverse event occurred during the treatment with op-08w and plasorba brs. This case was obtained from the doctor's inquiry to us. As the doctor is reluctant to our further investigation, the follow-up investigation like the patient's underlying disease and the cause of the this event is not possible. Although this adverse event is not written in the ifu of op, as this case is the first time to receive as op, so we will carefully continue to monitor and to be vigilant for the trend of occurrence of this kind of adverse events.
Patient Sequence No: 1, Text Type: N, H10
[137654689]
A patient was in the condition of postoperative hepatic failure in (b)(6). The patient's bilirubin value began to increase around the second day after the operation, although the laboratory data of the patient's coagulation factor was in the lower level, this patient's apheresis treatment with plasmflo op-08w, used as plasma separator and similar product of op-05w(a) sold in us, and plasorba brs, absorptive removal column of bilirubin and bile acid, to absorb bilirubin was started. The situation about the first treatment was unknown. In the end of (b)(6) 2018, the patient developed the pulmonary alveolar hemorrhage in the second treatment with op-08w and plasorba brs, and died after its treatment. The detail information about the medical treatment of the adverse event was unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2019-00010 |
| MDR Report Key | 8385341 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-04 |
| Date of Report | 2019-02-15 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2019-02-15 |
| Date Added to Maude | 2019-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2019-03-04 |
| 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. Death | 2019-03-04 |