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

Device Problems Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 10/15/2015

Event Type  malfunction  

Event Description

Patient's orthopat alarmed to check disk reservoir.I opened top lid of machine and noted some dried blood on inner ring, lifted gray metal ring up and found a yellow plastic cap with a small amount of dried and wet blood.This yellow cap is also noted to be used to close off the two tubes on top of the side collection chamber.Called the on call orthopat rep and they said to clean the blood out of the disk reservoir with bleach wipes and leave machine off.

• Brand Name: ORTHOPAT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree, MA 02184
• MDR Report Key: 5317939
• MDR Text Key: 34102663
• Report Number: 5317939
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR