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 2018-04-20 for PLASMAFLO OP OP-08W(L) manufactured by Asahi Kasei Medical Co., Ltd..
[106012200]
This incident of dyspnea occurred in (b)(6). And we are reporting this event to fda according to the requirement. Plasmaflo op-08w(l) is similar model of plasmaflo op-05w(a) marketed in u. S. The actual used products were not returned to u. S for investigation and could not be analyzed, however the lot number was reported. So we reviewed manufacturing records and quality records of lot#fg4p4u. As a result, no abnormality was found in the records. (b)(4) units of this lot#fg4p4u were manufactured and no similar event using this lot#fg4p4u was reported globally. Difficulty breathing(dyspnea), urticaria(cutaneous rash), and chest pain such as this case may occur during dialysis treatment and/or extracorporeal treatment from multiple factors such as patient condition (including primary disease and treatment condition), dialyzer (membrane material and compatibility), blood tubing, operating condition, treatment condition, medication interactions including anticoagulants and others. The caution for this event is described in instruction for use. Patient's physician considers that this case is serious event and that causal relationship between plasmaflo op and this event is possible, and reported this case to french competent authority. We also consider the severity of dyspnea is serious injury as patient's oxygen saturation decreased to 80% , and the causal relationship between this device and the event could not be denied because the event happened during the treatment.
Patient Sequence No: 1, Text Type: N, H10
[106012201]
A (b)(6)-year-old man was alternatively given the treatment with plasmapheresis(five pe sessions), and double filtration plasma apheresis(dfpp) of plasmaflo op-o8w(l) and cascadeflo ec-30w, and sodium citrate hydrate (acd-a) as the anticoagulant on plasauto sigma(two sessions). Patient experienced adverse events during 1st and 2nd dfpp as follows. (b)(6) 2018: after 5 min. From the beginning of fresh frozen plasma(ffp) infusion of dfpp, this patient developed choking sensations, drop of oxygen saturation to 80%, and cutaneous rash. The treatment was stopped. The patient was given the treatment of oxygen and iv polaramine (anti-histamine). (b)(6) 2018: after 10 min. From the patient's connection to dfpp(infusion of 4% albumin), he developed choking sensations, chest pains on the left side, and drop of oxygen saturation to 88%. Treatment of dfpp continued with iv polaramine (anti-histamine). He has recovered from the symptoms. On the other hand, this patient suffered similar adverse effects during a pe session on prismaflex with ffp on (b)(6) 2018 and with albumin on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2018-00020 |
| MDR Report Key | 7446041 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-04-20 |
| Date of Report | 2018-03-23 |
| Date of Event | 2018-01-12 |
| Date Mfgr Received | 2018-03-23 |
| Device Manufacturer Date | 2017-04-29 |
| Date Added to Maude | 2018-04-20 |
| 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 | 1-105, 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 | 2018-04-20 |
| Model Number | PLASMAFLO OP |
| Catalog Number | OP-08W(L) |
| Lot Number | FG4P4U |
| 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 | 4 | 1. Other | 2018-04-20 |