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

Catalog Number CAR-505

Device Problem Gas/Air Leak (2946)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/17/2019

Event Type  malfunction  

Event Description

Nurse reconnecting crrt after flushing line to check for patency, restarted crrt and witnessed large volume of air travel through access line through machine and return to pt.Bedside rn quickly stopped crrt but immediately noticed pt oxygen saturations drop to mid/low 80s.Pt vital signs improved <5 mins with application of nasal cannula.Fda safety report id# (b)(4).

• Brand Name: NXSTAGE CARTRIDGE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.
• MDR Report Key: 8573377
• MDR Text Key: 143951342
• Report Number: MW5086318
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAR-505
• Device Lot Number: 90178015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 103