NxStage PureFlow-B SolutionRecalls & reported problems across all models

We found 3 models of NxStage PureFlow-B Solution by Nxstage Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Apr 3, 2018 and Apr 3, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

NxStage PureFlow-B Solution recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 10, 2017Terminated

   Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.

   Z-1132-2018 · Root cause: Labeling design · names 2 of these models · Recall details · FDA record ↗

Most reported NxStage PureFlow-B Solution problems

NxStage PureFlow-B Solution models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NxStage PureFlow-B Solution RFP-400-BB

  Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
  1 recall0 reports
• NxStage PureFlow-B Solution RFP-401-BB

  Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
  1 recall0 reports
• NxStage PureFlow B Solution RFP-404

  Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
  1 report

Recent NxStage PureFlow-B Solution adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2018Break

  TWO HEMODIALYSIS BAGS POPPED DURING ACTIVATION COULD NOT BE USED FOR DIALYSIS. NEW BAGS WERE OBTAINED FROM PHARMACY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7391748 ↗

Other Nxstage Medical, Inc. products

• NXSTAGE CARTRIDGE EXPRESS4 models · 206 reports