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 2019-04-18 for PLASMAFLO OP OP-05W(A) N/A manufactured by Asahi Kasei Medical Co., Ltd..
[142320346]
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 u. S. The product in complaint was not returned to the manufacturer and could not be analyzed. The lot number in complaint was not reported and we could not review the manufacturing and quality control records. According to the physician comment about the relationship between this product and the patient's death, this treatment of op and prasorba brs might have caused the patient's early death. We judged that this case as serious adverse event because the outcome is death. The causal relationship between these events and op are not denied because the patient's clinical laboratory data were aggravated after the treatment, and that this patient died 6 hours after the end of the treatment. This case information was derived from the inquiry from the customer, so follow-up information about the cause of the death could not be obtained. The caution as to the patients with low platelet count is written in the ifu as follows. In the "e. Precautions", as "15. The plasmaflo? Op-05w(a) is not recommended for use with the following patients, except where specifically approved by and used in accordance with the directions of the responsible physician. Patients with low platelet count" however, "platelet count decreased, prothrombin time prolonged" is not written in the ifu, but this case is their first adverse events for us to receive, we will continue to monitor the occurrence of these kinds of events.
Patient Sequence No: 1, Text Type: N, H10
[142320347]
This case occurred in the facility of (b)(6). On (b)(6) 2019: the level of this patient's blood pressure was low from the morning, and the patient's aspiration was managed with the ventilator before bilirubin adsorption treatment. This patient was treated with bilirubin adsorption treatment of plasmaflo op-05w 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. Patient's platelet count decreased from 116,000/ul to 102,000/ul. Prothrombin time increased from 15. 6 seconds to 22. 5 seconds. On (b)(6) 2019: this patient was treated with bilirubin adsorption therapy. Platelet count decreased from 102,000 /ul to 82,000 /ul. Prothrombin time increased from 19. 1 seconds to 29 seconds. 13:25, the treatment with bilirubin adsorption therapy was stopped. No bleeding around the catheter at the vascular access of the groin. 19:18, this patient has died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2019-00040 |
| MDR Report Key | 8525799 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-18 |
| Date of Report | 2018-03-22 |
| Date of Event | 2019-03-19 |
| Date Mfgr Received | 2019-03-22 |
| Date Added to Maude | 2019-04-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-04-18 |
| 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 | 2019-04-18 |