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 2018-05-09 for PLASMAFLO OP OP-05W NA manufactured by Asahi Kasei Medical Co., Ltd..
[107694678]
This incident of eosinophilic pneumonia occurred in (b)(6), and we are reporting this event to fda according to the requirement. Plasmaflo op-05w is similar model of plasmaflo op-05w(a) marketed in us. The actual used product was not returned to us for investigation and could not be analyzed, and the lot number was unknown. We have not received any event of eosinophilic pneumonia other than this case since we started selling plasmaflo op globally. Patient's physician considers that this case is serious event and that causal relationship between plasmaflo op and this event is possible, and the doctor whose hospital this patient was transferred to commented that this case is possibly related to iapp. We also consider the severity of eosinophilic pneumonia is serious injury as patient has hospitalized for the treatment of pneumonia and was given the treatment of mechanical ventilator, and the causal relationship between this device and the event could not be denied because the event happened just after iapp treatment. The caution for this event is not described in instruction for use, however this case is the first event happened on plasmaflo op, we will continue to vigilance trend in occurring this kind of event(eosinophilic pneumonia) with plasmaflo op.
Patient Sequence No: 1, Text Type: N, H10
[107694679]
A (b)(6) woman started the treatment with immunoadsorption plasmapheresis(iapp) of plasmaflo op-o5w and immusorba tr-350 for myasthenia gravis on (b)(6), and was given the treatment with iapp on (b)(6). On (b)(6) 2018, she was given the seventh treatment with iapp of plasmaflo op-o5w and immusorba tr-350 for myasthenia gravis. Just after catheter withdrawal, this patient experienced respiratory discomfort. Conclusion of air in her blood was suspected to have occurred, and chest x-ray was taken, which showed opacity like the diffuse pneumonia in her left lung. Soon after she returned to the hospital ward, her symptom worsened and oxygen was given via oxygen mask, but still she could not maintain her breathing, and she was given the treatment with ventilator. Acute respiratory distress syndrome(ards) was suspected, and she was given the treatment of antibiotic meropenem and elaspol, but she could not wean from mechanical ventilator. On (b)(6) 2018, this patient was admitted to another hospital, and was given the treatment with antifungal agent for allergic bronchopulmonary mycoses. In the end of march, she was given the conservative medical management. She has recovered and was discharged from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2018-00040 |
| MDR Report Key | 7497644 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-05-09 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-04-13 |
| Date Added to Maude | 2018-05-09 |
| 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 | 1-105, KANDA JINBOCHO CHIYODA-KU |
| Manufacturer City | TOKYO 101-8101 |
| Manufacturer Country | JA |
| Manufacturer Postal | 101-8101 |
| Manufacturer Phone | 32963735 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASMAFLO OP |
| Generic Name | PLASMA SEPARATOR |
| Product Code | MDP |
| Date Received | 2018-05-09 |
| Model Number | OP-05W |
| Catalog Number | NA |
| Lot Number | NA |
| 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 | 1-105, KANDA JINBOCHO CHIYODA-KU TOKYO 101-8101 JA 101-8101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-05-09 |