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 2019-05-12 for PLASMAFLO OP OP-05W N/A manufactured by Asahi Kasei Medical Co., Ltd..
[144801673]
This incident occurred in (b)(6) and is reported to fda according to the requirement. Op-05w is identical model to op-05w(a) marketed in us. The product of this event was not returned to the manufacturer and could not be analyzed. The lot number of the product was not reported and we could not review the manufacturing and quality control records. According to the physician's comment, her treatments of dfpp from the first one to the fourth one were performed without any problem. After several hours from the end of the fifth treatment of dfpp, she developed acute pulmonary oedema, as the result of elevation of her blood vessel permeability caused by the allergic reaction etc. The cause of this event was known, either by the displacement liquid or by dfpp. The physician considered that this event was not caused by op because this event occurred several hours after the end of the dfpp treatment, but that the causal relationship between this event and op was not denied as direct cause of this event was not identified. We considered that this event was serious adverse event because the outcome was death. The causal relationship between the event and op was not denied, because the patient experienced the acute pulmonary oedema after her dfpp treatment. The caution as to this event is not written in the package insert of op, but this case is the first adverse event whose causal relationship was not denied for us to receive, we will continue to monitor the occurrence of these kinds of events.
Patient Sequence No: 1, Text Type: N, H10
[144801674]
This case occurred in the facility of (b)(6). On (b)(6) 2019: this patient was started with the fifth treatment of double filtration plasma exchange(dfpp) of op-05w, which was used as plasma separator and was similar product of op-05w(a) sold in us, and cascadeflo ec-20w, which fractionate plasma into large and small molecular weight components. After three hours from the beginning of the treatment, her treatment finished, and she returned her room. After four hours from the end of the treatment, she was found fallen down in the rest room. After four hours and half from the end of the treatment, her hemoglobin(hb) value increased to 17. 8 g/dl. After seven hours from the end of the treatment, the result of the computed tomography scan test showed suspected pneumonedema. After seven hours and forty five minutes from the end of the treatment, her hb value increased to 20. 4 g/dl. After eight hours from the end of the treatment, her aspiration was supported with the noninvasive positive pressure ventilation(nppv), but did not improve, so she was given the treatment with cannulation. She was diagnosed as acute respiratory failure, acute heart failure, and acute pulmonary oedema, and was transferred to the intensive-care unit. On (b)(6) 2019: after 13 hours from the end of the treatment, the patient experienced acidosis, and was given the treatment with continuous renal replacement therapy (crrt). After 15 hours from the end of the treatment, the patient has died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2019-00070 |
| MDR Report Key | 8602378 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-12 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-05-12 |
| 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 | 2019-05-12 |
| Model Number | OP-05W |
| 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 | 2019-05-12 |