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

Model Number 1050-240-XXX

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated for the issue of no power.During the evaluation, a spill was found internal to the device.The power supply unit, all drain tubes, the compressor, and distribution pcb were all damaged.There was no evidence of arcing or sparking and no carbonization noted.The device was decontaminated, repaired and upgraded to the current fluid ingress remediation which mitigates the risk for damage due to fluid spills.

Event Description

Haemonetics received a report on (b)(6) 2015 stating there was power failure and machine would not turn on while utilizing the orthopat device.No patient or operator injury reported.

• 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: 5336256
• MDR Text Key: 35178244
• Report Number: 1219343-2015-00038
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K992723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1050-240-XXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2011
• 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