CWP 60 SYSTEM (CENTRAL WATER TREATMENT SYSTEM FOR HEMODIALYSIS) 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 BAXTER CORPORATION 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    71414
  • 사례 위험등급
    II
  • 사례 시작날짜
    2016-11-21
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Baxter corporation is issuing a device correction for specific models of the central water plant (cwp) reverse osmosis units in order to correct the insufficient crimping of the cables within the main pump. the issue was identified as a result of customer complaints received for the presence of smoke in the water treatment room due to the overheating of the pump in the cwp. as part of baxter's investigation based on pictures provided from the event the most likely cause of the thermal event was due to the crimp of the cables for the main pump being insufficient. to minimize any potential side effects of thermal events please ensure all panels of the cwp are in place.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: WRO63 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 106H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 104S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO112 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO113 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO111 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO101H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO104H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 106S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO101S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103H(P) (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102H(P) (Lot serial: > 100 numbers contact m
  • 제품 설명
    Central Water Plant Reverse Osmosis Unit (CWP 60);Central Water Plant Reverse Osmosis Unit (CWP 100)
  • Manufacturer

Manufacturer