International safety notice
A medical institution recommends that the automatic peritoneal perfusion device APD device PD-Relaxa (hereinafter referred to as Relaxa) be used to complete treatment. We received a report that some fluid remained in the peritoneal dialysis solution bag after the procedure was completed. As a result of the investigation, it was found that the opening operation of the stopper of the peritoneal dialysis fluid bag was insufficient, and that the internal setting of Relaxa had a "feeling of occlusion". If the setting value of "Date" is set to "Low", the fluid volume may not be measured correctly, causing fluid to leak into the peritoneal dialysis fluid bag. I decided it was left over.
Japan / PMDA Recalls · JPN · Jul 23, 2024
Key facts
| Title | A medical institution recommends that the automatic peritoneal perfusion device APD device PD-Relaxa (hereinafter referred to as Relaxa) be used to complete treatment. We received a report that some fluid remained in the peritoneal dialysis solution bag after the procedure was completed. As a result of the investigation, it was found that the opening operation of the stopper of the peritoneal dialysis fluid bag was insufficient, and that the internal setting of Relaxa had a "feeling of occlusion". If the setting value of "Date" is set to "Low", the fluid volume may not be measured correctly, causing fluid to leak into the peritoneal dialysis fluid bag. I decided it was left over. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Automatic peritoneal perfusion device Brand name: APD device PD-Relaxa |
| Manufacturer | JMS Co., Ltd. |
| Models | 2401345, 2304050, 2312281, 2307110, 2306071, 2311231, 2401331, 2311280, 2305051, 2306090, 2310190, 2304001 and 6 more |
| Date | Jul 23, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1