International safety notice
A clogged Dräger sterilization filter (Safestar) from an overseas manufacturer was used on patients undergoing anesthesia. We have received reports that one case has been reported overseas where a patient became hypoxic and required resuscitation. The Dräger sterilization filter (Safestar) uses a filter to detect blockage of the filter. A 100% inspection (resistance test) is conducted after each product is manufactured. If the resistance test fails, the failed filter is automatically discarded. However, because the automatic disposal function was stopped during maintenance of the manufacturing equipment for the filter, A manual selection process was carried out. Although the filter used in this case failed the resistance test conducted, It turned out that due to a human error, the product was placed in the "passed" box instead of being disposed of. Ta. Based on our supply chain and delivery history, all potentially affected products, with the exception of one reported case, are: We believe that there is a high possibility that it does not exist on the market, but we have determined that it is not possible to eliminate it 100%. We have decided to begin collection.
Japan / PMDA Recalls · JPN · May 10, 2022
Key facts
| Title | A clogged Dräger sterilization filter (Safestar) from an overseas manufacturer was used on patients undergoing anesthesia. We have received reports that one case has been reported overseas where a patient became hypoxic and required resuscitation. The Dräger sterilization filter (Safestar) uses a filter to detect blockage of the filter. A 100% inspection (resistance test) is conducted after each product is manufactured. If the resistance test fails, the failed filter is automatically discarded. However, because the automatic disposal function was stopped during maintenance of the manufacturing equipment for the filter, A manual selection process was carried out. Although the filter used in this case failed the resistance test conducted, It turned out that due to a human error, the product was placed in the "passed" box instead of being disposed of. Ta. Based on our supply chain and delivery history, all potentially affected products, with the exception of one reported case, are: We believe that there is a high possibility that it does not exist on the market, but we have determined that it is not possible to eliminate it 100%. We have decided to begin collection. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Breathing circuit sterilization filter Brand name: Dräger sterilization filter (Safestar) |
| Manufacturer | Dräger Japan Co., Ltd. |
| Models | LT2103 |
| Date | May 10, 2022 |
| 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