MAUDE Adverse Event Report: HAEMONETICS CORP. ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

Catalog Number 1050-110-ENG

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2014

Event Type  malfunction  

Event Description

Haemonetics received a report on (b)(4) 2014 for an orthopat device "blood spill - made it into the containment bag - no additional information on the source of the spill." there was no report of any patient or operator injury.

Manufacturer Narrative

The device was returned and evaluated.There was a fluid spill found dripping down the distribution pcb, power supply and chassis.There was a minor spill on the driver board and controller pcb.No carbonization found.Device cleaned and upgraded to the current fluid remediation.(b)(4).

• Brand Name: ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM
• Manufacturer (Section D): HAEMONETICS CORP.; 400 wood rd.; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd.; braintree, MA 02184 ; 7814367209
• MDR Report Key: 3785002
• MDR Text Key: 4436375
• Report Number: 1219343-2014-00005
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K9972723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1050-110-ENG
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1219343-04/29/2011-001-R
• Patient Sequence Number: 1