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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 1050-240-XXX
Device Problems Nonstandard Device (1420); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2014
Event Type  malfunction  
Event Description
Haemonetics received a report on (b)(4) 2014 for an orthopat device with a complaint of "return for checking and blood spillage." no patient or operator injury reported.
 
Manufacturer Narrative
The device has not been returned for service.A supplemental report will be sent when the device is received and the evaluation is complete.(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 ann smith, rn
400 wood rd.
braintree, MA 02184
7819170643
MDR Report Key4340759
MDR Text Key5215269
Report Number1219343-2014-00028
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
Reporter Country CodeLU
PMA/PMN Number
K992723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Not Applicable
Remedial Action Recall
Type of Report Initial
Report Date 11/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1050-240-XXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2003
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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