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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 Nonstandard Device (1420); Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/15/2014
Event Type  malfunction  
Event Description
Haemonetics received a report on (b)(4) 2014 for an orthopat device with a spill while removing kit.No injuries reported.
 
Manufacturer Narrative
The device was returned and evaluated for the reported issue.During the evaluation, the device would not power on and a large saline spill was found internal to the device.The spill was found inside the power supply, driver board, centrifuge assembly, cover lock, and top deck distribution pcb.There was no evidence of carbonization, arcing or sparking.This device will be cleaned, repaired and upgraded to the current fluid ingress remediation.(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 Key3869512
MDR Text Key4508153
Report Number1219343-2014-00013
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 04/15/2014
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 Number1050-110-ENG
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/18/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/15/2014
Initial Date FDA Received04/30/2014
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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