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

Catalog Number 1050-110-ENG

Device Problems Nonstandard Device (1420); Smoking (1585); Chemical Spillage (2894)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

Haemonetics received a report on (b)(6) 2015 for an orthopat device with a complaint of "fluid spill with smoke.No pt or operator issues associated.".

Manufacturer Narrative

The device was returned for evaluation.Fluid ingress was found.Blood was found in the power supply, under centrifuge chuck, and on ac filter, distribution pcba, manifold, vacuum tank, cables, tubing, top deck, outer skin, and chassis floor.Machine will not power up dur to blown fuse.Carbonization was found in the power supply and on the manifold.This device will be upgraded to the fluid ingress remediation which mitigates the risk for damage due to fluid spills.(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.; p.o. box 9114; braintree, MA 02184 ; 7819170643
• MDR Report Key: 4490767
• MDR Text Key: 5567157
• Report Number: 1219343-2015-00002
• 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: 01/19/2015

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-ENG
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2015
• Initial Date FDA Received: 02/04/2015
• Date Device Manufactured: 09/01/2003
• 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