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

Model Number 1050-110-JPN

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

The haemonetics field service engineer evaluated the device.It was confirmed that there was a disk leak which resulted in fluid ingress.The ingress caused damage to the electronic components which caused the fuse to blow.This device will be repaired and upgraded to the current fluid ingress remediation which mitigates the risk for damage due to fluid spills.

Event Description

Haemonetics received a complaint on 10/27/2015 stating that a "dsk leak occurred during intra-op use.The process was stopped because blood leakage was suspected.Smoke from the device was confirmed.".

• 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: 5320964
• MDR Text Key: 34917019
• Report Number: 1219343-2015-00017
• 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
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1050-110-JPN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2011
• 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