MAUDE Adverse Event Report: STRYKER CBC 11 CONSTAVAC; BLOOD CONSERVATION SYSTEM

Model Number 225-28-104 RCVB

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

Patient came from surgery to recovery with constavac.The nurse asked the physician what level to start at.When the nurse turned on the device it did not function.Connection to patient was checked by nurse and everything was connected properly.Turned device on again but it did not start.Changed out device and the new constavac functioned properly.No harm to patient.

• Brand Name: CBC 11 CONSTAVAC
• Type of Device: BLOOD CONSERVATION SYSTEM
• Manufacturer (Section D): STRYKER; san jose CA
• MDR Report Key: 3874138
• MDR Text Key: 4563533
• Report Number: MW5036594
• Device Sequence Number: 1
• Product Code: CAC
• 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: 06/06/2014

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 Model Number: 225-28-104 RCVB
• Device Lot Number: 14062012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR