MAUDE Adverse Event Report: NXSTAGE NXSTAGE CVVH FILTER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Lot Number 10478022

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

When priming cvvh filter, the rn noted the cvvh filter had two pin sized holes in the ¿bubbles¿ that go on the inside of the machine.The rn circled the spots on the filter and set filter aside for review.This delayed the patient getting dialysis in timely manner as a new filter needed to be primed.

• Brand Name: NXSTAGE CVVH FILTER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 12868675
• MDR Text Key: 281207362
• Report Number: 12868675
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 10478022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13140 DA
• Patient Sex: Male
• Patient Weight: 121 KG
• Patient Race: Black Or African American