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

Model Number 10A031

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Device Contamination with Body Fluid (2317)

Patient Problem No Information (3190)

Event Date 01/30/2014

Event Type  No Answer Provided  

Event Description

Orthopat used on postoperative patient.Machine alarming, and blood was found in the side pouch alerting machine malfunction.Side pouch collects blood that leaks into collection area.Top of machine opened and found to have blood in top circular area and through machine (drain hole) to collection pouch.Drain d/c and machine sent for cleaning.The metal area holding the flat disposable unit is hard to clean - blood sticks to the rough surface.Also tiny drain chamber has to be cleaned with flushing and brushes.

• Brand Name: ORTHOPAT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 179 campanelli parkway; stoughton MA 02072
• MDR Report Key: 3631465
• MDR Text Key: 4209527
• Report Number: 3631465
• 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

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Nurse
• Device Model Number: 10A031
• 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
• Patient Sequence Number: 1
• Patient Age: 47 YR