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

Catalog Number 1050-110-JPN

Device Problems Failure to Power Up (1476); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

Haemonetics received a report on 02/24/2015 for an orthopat device with a complaint that the device displayed a "centrifuge speed error" , "check inlet fluid path" and "check effluent fluid path" messages during intra-op.The keypad then became non-functional.The equipment was turned off by unplugging the device.After that the operator attempted to turn it back on, but the device would not power on.Upon removing the disk from the centrifuge, saline was found in the centrifuge chamber and the diaphragm was found to be torn.No adverse experience reported.No other information was provided.

Manufacturer Narrative

The device was returned for evaluation.Fluid ingress was found due to the leak in the dynamic disk.Blood was found on the driver board and into the power supply.No carbonization, burning or arcing was found.The device was cleaned and decontaminated.The parts were replaced due to the contamination.The device will be returned to the customer.

• Brand Name: ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd; braintree, MA 02184 ; 7819170643
• MDR Report Key: 4628166
• MDR Text Key: 5656095
• Report Number: 1219343-2015-00004
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K992723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/24/2015

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-JPN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2015
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1219343-04/29/2011-001-R
• Patient Sequence Number: 1