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

Model Number 1050-110-ENG

Device Problem Failure to Power Up (1476)

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

Event Date 03/18/2015

Event Type  malfunction  

Event Description

Haemonetics received a report from the customer that their orthopat device would not power on.

Manufacturer Narrative

Haemonetics received the device back on 03/30/2015 to evaluate the reported issue of the device not powering on.When the device was evaluated is was discovered that there was a large saline spill into the device.The saline ingressed into the power supply and caused the power supply and components to burn.No other parts were affected as a result of the spill.The device was decontaminated, repaired and upgraded to the current fluid ingress remediation which mitigates the risk for damage due to fluid spills.

• 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: 4745326
• MDR Text Key: 5772309
• Report Number: 1219343-2015-00005
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1050-110-ENG
• Device Catalogue Number: 1050-110-ENG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1219343-04/29/2011-001-R
• Patient Sequence Number: 1