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

Catalog Number 1050-110-ENG

Device Problems Nonstandard Device (1420); Device Contamination with Body Fluid (2317)

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

Event Date 08/27/2014

Event Type  malfunction  

Event Description

Haemonetics received a report on (b)(6) 2014 for an orthopat device with a complaint of "orthopat machine blood spill.No add'l info provided." no pt or operator injury reported.

Manufacturer Narrative

The device was returned for eval and cleaning.There was blood on the dc connector on the power supply, the cable from the driver board to the top deck distribution board, on the bottom of the chassis, the black centrifuge ring and the top deck distribution board.This device needed to be upgraded to the fluid ingress remediation which mitigates the risk of fluid from entering the key electronic components.The device will be repaired, cleaned and returned for service.(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 ; 7819170643
• MDR Report Key: 4144314
• MDR Text Key: 4766136
• Report Number: 1219343-2014-00026
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992723
• 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: 08/27/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1050-110-ENG
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2005
• 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