MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NT821731C, EDS 3, GEN LL, NO CATHETER

Model Number NT821731C

Device Problems Backflow (1064); Decrease in Pressure (1490)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

Csf backflow witnessed in natus eds drain that was placed in stroke patient on jan 17.Rns noticed csf backflow all the way past the system stopcock.Pressure level was set to 10 mmhg, dropped drip chamber to pressure level of 5 mmhg and still witnessing backflow all the way through drainage tubing to system stopcock.No patient injury, performance failure.Part number of the affected parts to be confirmed.Event 2/2.

Manufacturer Narrative

Initial report ref to natus complaint (b)(4).Complaint forms were received for both events.Section d4 to be completed - technical service has requested confirmation on the part and lot number of the product.The customer has been requested to return the product for evaluation.Risk review: per (b)(4) rev 08 risk analysis spreadsheet (ras) - natus eds 3 external drainage system hazard id 2.2 - cerebrospinal fluid (csf) with leachables flows back to the patient ventricular/lumbar.Effect (harm): adverse tissue reaction.Residual risk: medium.

• Brand Name: NT821731C, EDS 3, GEN LL, NO CATHETER
• Type of Device: NT821731C, EDS 3, GEN LL, NO CATHETER
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego; CA 92121
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 18640381
• MDR Text Key: 336056336
• Report Number: 2023988-2024-00013
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT821731C
• Device Catalogue Number: NT821731C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1