MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number NX1000-5

Device Problem Output Problem (3005)

Patient Problems Pulmonary Edema (2020); Low Oxygen Saturation (2477)

Event Date 09/30/2020

Event Type  malfunction  

Event Description

Medical icu at 1900 registered nurse reported: critically ill patient started on cvvh (continuous veno-venous hemofiltration) and had been running negative.Despite running negative on cvvh patient had significant increase in generalized edema.Five days later, patient acutely decompensated after a turn, desaturated to 70%.Required increase fi02 to 100%, and increased peep (positive end-expiratory pressure) to 20.Also required chemical paralysis and significant increase in sedation.Chest x-ray showed worsening pulmonary edema.Exchanged cvvh machine, questioning whether volume was actually being removed from the patient given significantly worsening clinical presentation indicating increase volume overload.Once new cvvh machine running for several hours able to wean down fi02.By the end of shift fi02 down from 100% to 40%, and there was visible improvement in patient's edema.Manufacturer response for cvvhd system, cvvh (per site reporter).

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack st; lawrence MA 01843
• MDR Report Key: 15939415
• MDR Text Key: 305058111
• Report Number: 15939415
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NX1000-5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA