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 2018-06-26 for PLASMAFLO OP OP-05(A) N/A manufactured by Asahi Kasei Medical Co., Ltd..
[112855243]
This incident, "leakage from the arterial connector through the small crack" happened in germany, and was noticed by the nurse, just after the treatment started. We are reporting this incident to fda according to the requirement. Plasmaflo op-05w(l) is similar model of plasmaflo op-05w(a) marketed in us. The used device could not analysed because it was discarded by the user facility. We investigated the manufacturing and quality control records of the lot number and no abnormality was found. Furthermore, no similar complaint was reported by other facilities at this moment. Consequently, the root cause of the event could not be identified as only the insufficient information was available. The caution for "blood leakage" is described in precautions of the package insert as 14. If any problem such as the following occurs during treatment with the plasmaflo op-05w(a), immediately ensure the safety of the patient and take appropriate measures, such as discontinuation of the treatment or replacement of the plasmaflo op-05w(a), in accordance with the directions of the responsible physician. ; leakage in the membrane or the extracorporeal circuit. We decided to report this incident since we consider blood leakage from the arterial connector is an incident which might cause serious injury to the patient. We understand the importance of quality control, and we assure you that we will continue to investigate all possible methods for improving the quality of our products, and to be vigilant for the trend in occurring this kind of incident.
Patient Sequence No: 1, Text Type: N, H10
[112855244]
On (b)(6) 2018: just after starting the treatment with apheresis session of op-05w(l), the nurse realized that the blood was dripping out of its arterial connector, where its small crack was found. After the filter was changed to new one, the treatment was continued. Priming and rinsing volume: 2,000ml respectively, qb 100ml/min. , qf 30ml/min. No adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2018-00120 |
| MDR Report Key | 7636738 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-06-26 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-05-03 |
| Date Mfgr Received | 2018-05-30 |
| Device Manufacturer Date | 2017-03-03 |
| Date Added to Maude | 2018-06-26 |
| 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 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 | 2018-06-26 |
| Model Number | OP-05(A) |
| Catalog Number | N/A |
| Lot Number | GG2K33 |
| 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. Other | 2018-06-26 |