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 2019-05-27 for PLASMAFLO OP OP-08W N/A manufactured by Asahi Kasei Medical Co., Ltd..
[146224894]
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, and is used as plasma separator. We reviewed manufacturing records, quality records of lot# mh5p61. As a result, no abnormality was found in records. No similar event using this lot# mh5p61 was reported globally. Physician considered that this event was serious adverse event of "hemolysis", and the causal relationship between this event and plasmaflo op could not be denied. We could not obtain detail information of this event, according to physician's comment, we considered that this event was serious, and that the causal relationship between plasmaflo op and this event could not be denied because the adverse event occurred during the treatment with op-08w. Hemolysis is described in the package insert of plasmaflo op (i. Preface, e. Precautions): 12. Hemolysis is an adverse reaction that can occur if the tmp increases above 100mmhg (13. 3kpa). 13. Monitor the patient constantly during treatment with the plasmaflo op-05w(a). In the event of any of the following during treatment, immediately ensure the safety of the patient and take appropriate measures in accordance with the directions of the responsible physician. Presence of hemoglobin in separated plasma, due to hemolysis. 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
[146224895]
This case occurred in (b)(6). A patient's underlying disease was uraemia. The double filtration plasmapheresis (dfpp) treatment was required to be performed in order to reduce the patient's antibodies before his kidney-transplant surgery. Just after the start of the treatment of dfpp using plasmaflo op-08w used as plasma separator, which is similar product of plasmaflo op-05w(a) marketed in us, the bright red liquid was observed in the separated plasma. The medical staffs judged that the possibility of the patient's hemolysis reaction was suspected, his treatment was stopped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2019-00080 |
| MDR Report Key | 8643805 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-27 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-04-29 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-05-27 |
| 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 | 1-1-2 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 | 2019-05-27 |
| Model Number | OP-08W |
| Catalog Number | N/A |
| Lot Number | MH5P61 |
| 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 | 2019-05-27 |