MAUDE Adverse Event Report: HAEMONETICS CORPORATION ORTHOPAT; APPARATUS, AUTOTRANSFUSION

Model Number 10A031

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 02/04/2014

Event Type  No Answer Provided  

Event Description

User setting up orthopat machine reported "stop cocks not working well." would not process blood and kept reading "check saline bag." blood was bubbling in reservoir.Unable to easily remove 1 stopcock from machine.Transferred blood components to other machine.Clinical engineer believes machine turned off during cycle where stop cock was turned preventing removal of stop cock.Turned back on, machine turned stop cock, and then was able to remove the disposables.Unsure why event occurred with alarm and bubbling in reservoir.

• Brand Name: ORTHOPAT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 179 campanelli parkway; stoughton MA 02072
• MDR Report Key: 3631467
• MDR Text Key: 20718265
• Report Number: 3631467
• Device Sequence Number: 1
• Product Code: CAC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2014

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?: *
• Device Operator: Nurse
• Device Model Number: 10A031
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2014
• Patient Sequence Number: 1
• Patient Age: 68 YR