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 2019-03-20 for PLASMAFLO OP OP-08W N/A manufactured by Asahi Kasei Medical Co., Ltd..
[139292618]
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# mh4z4l. As a result, no abnormality was found in records. 1,380 units of this lot# mh4z4l were manufactured, and no similar event using this lot# mh4z4l 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. ? E 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
[139292619]
A patient was in the condition of chronic renal failure in (b)(6). The patient was planned to have a kidney-transplant surgery, and double filtration plasmapheresis (dfpp) treatment was required to performed because of the patient's high level of antibodies. (b)(6) 2019: after 10 minutes from the blood was introduced to the circulation of dfpp using plasmaflo op-08w used as plasma separator, which is similar product of plasmaflo op-05w(a) marketed in us, bright red liquid was observed in the plasma-room. The doctor thought it may be a hemolysis reaction, and the treatment was stopped. The liquid sample was sent for further test (hemolysis was confirmed). The patient recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2019-00030 |
| MDR Report Key | 8435441 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-20 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-01-24 |
| Date Mfgr Received | 2019-02-25 |
| Device Manufacturer Date | 2018-04-21 |
| Date Added to Maude | 2019-03-20 |
| 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 | 2019-03-20 |
| Returned To Mfg | 2019-03-06 |
| Model Number | OP-08W |
| Catalog Number | N/A |
| Lot Number | MH4Z4L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-20 |