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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAEMONETICS CORP. ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM
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HAEMONETICS CORP. ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM Back to Search Results
Catalog Number 1050-110-ENG
Device Problems Device Emits Odor (1425); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2013
Event Type  malfunction  
Event Description
Haemonetics received a report on (b)(6) 2013 for an orthopat machine "post-op no rbcs collecting in rbc bag.Machine had burning odor." no report of patient or operator injury.
 
Manufacturer Narrative
The device was evaluated and fluid ingress was found.There was burning damage noted to the power supply, distribution board and ac line filter.There was no report or harm to either the operator or patient.This device being upgraded to the current fluid ingress remediation.Haemonetics (b)(4).
 
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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.
braintree, MA 02184
7814367209
MDR Report Key3784369
MDR Text Key4379956
Report Number1219343-2014-00001
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992723
Number of Events Reported1
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 12/19/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1050-110-ENG
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/06/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/19/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction Number1219343-04/29/2011-001-R
Patient Sequence Number1
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