MAUDE Adverse Event Report: HAEMONETICS CORP. ORTHOPAT; APPARATUS, AUTOTRANSFUSION

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

Removing patient drains and orthopat collection system, lifted header to remove disposables.Blood immediately started pouring out from the disposable set where tubing meets disc.

• Brand Name: ORTHOPAT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORP.; 400 wood road; braintree MA 02184
• MDR Report Key: 3788216
• MDR Text Key: 4441734
• Report Number: 3788216
• 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: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 88