MAUDE Adverse Event Report: NXSTAGE MEDICAL INC. CRRT KIDNEY CAR-500; CRRT CIRCUIT

Lot Number 60678008

Device Problems Air Leak (1008); Collapse (1099); Increase in Pressure (1491); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2016

Event Type  Injury  

Event Description

Pt crrt circuit started alarming for high access pressures.Crrt tubing noted to be collapsing in on itself especially venous line.Pressure access pod would also immediately refill with air after being reset appropriately.Diagnosis or reason for use: dialysis.Is the product compounded? no.Is the product over-the-counter? no.

• Brand Name: CRRT KIDNEY CAR-500
• Type of Device: CRRT CIRCUIT
• Manufacturer (Section D): NXSTAGE MEDICAL INC.
• MDR Report Key: 6020257
• MDR Text Key: 57275596
• Report Number: MW5065317
• Device Sequence Number: 1
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 60678008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR