MAUDE Adverse Event Report: LIVA NOVA DEUTSCHLAND GMBH STOPCOCK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number 132434

Device Problems Fluid/Blood Leak (1250); Improper Flow or Infusion (2954)

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

Event Date 01/20/2019

Event Type  Injury  

Event Description

Nurse changing medication line connected to ecmo circuit.When stopcock closest to circuit was turned off, blood spilled from opposite end of the stopcock.Circuit was clamped <30 seconds , the stopcock was changed and blood products were pushed to restore flows.

• Brand Name: STOPCOCK
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVA NOVA DEUTSCHLAND GMBH; houston TX 77058
• MDR Report Key: 8286423
• MDR Text Key: 134636009
• Report Number: MW5083444
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• 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: 01/24/2019

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 Catalogue Number: 132434
• Device Lot Number: 1806700057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2019
• 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): Required Intervention
• Patient Age: 4 YR