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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYSMEX CORPORATION SYSMEX CA-1500 ANALYZER; AUTOMATED BLOOD COAGULATION ANALYZER

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SYSMEX CORPORATION SYSMEX CA-1500 ANALYZER; AUTOMATED BLOOD COAGULATION ANALYZER Back to Search Results
Model Number CA-150
Device Problem Insufficient Information (3190)
Patient Problems Venipuncture (2129); Needle Stick/Puncture (2462); Test Result (2695)
Event Date 03/20/2014
Event Type  Other  
Event Description
A siemens customer service engineer (cse) reported that he was injured while performing preventive maintenance activities on a ca-1500cp automated blood coagulation analyzer with cap piercer (serial number (b)(4)).He was changing the cap piercer on the analyzer and his thumb was penetrated by the sharp piercer.The cse was wearing the appropriate personal protective equipment (ppe) at the time of the event, which was approximately 3pm.The incident was reported as an exposure to environmental health and safety ()ehs) through siemens.The cse was treated at the emergency room of the client's site, receiving prophylactic anti-viral medication that is consistent with the centers for disease control's (cdc) virus-prevention guidelines.The cses status is monitored and will continue to be six months post-exposure ((b)(6) 2014).Results of six-week testing were negative.Siemens reports that the cse's condition is normal.
 
Manufacturer Narrative
The sysmex ca-1500 automated blood coagulation analyzer with cap piercer was not the direct cause of, but was involved in, the reported event.The user is warned in the sysmex ca-1500 system operator's manual introduction precautions to be observed in safe handling of the unit.The following is included: warning! handle the piercer with care.The top of the piercer is sharp.If it touches your hands or fingers, you may be injured or be infected.Be careful, specifically when replacing".The cse, who is familiar with the instrument's parts and configuration, reached inside of the cap piercer assembly to change the part.This area may be accessed by a user.The piercer is a consumable part required to be replaced at least every 30,000 cycles or when the piercer becomes worn or bent.Directions for its replacement are detailed in chapter 7 - maintenance and supplies replacement, section 7.7.Replacing the piercer warnings are included: "warning! the tip of the piercer is sharply pointed and extremely dangerous.When replacing the piercer, wear latex or non-latex examination gloves and do not touch the piercer tip.After operation is completed, wash your hands with disinfectant".The person performing this procedure is advised to hold the piercer base that is held by the fastening screw and remove the fixture that fixes the piercer.The person is instructed not to touch the bottom of the piercer guide.The surface that impaled the engineer's thumb was sharp, and the thumb's location to remove the cap piercer was such that the skin was penetrated.No evidence was provided to suggest that the analyzer was in operation, a part was not installed correctly or that the device failed in any way.
 
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Brand Name
SYSMEX CA-1500 ANALYZER
Type of Device
AUTOMATED BLOOD COAGULATION ANALYZER
Manufacturer (Section D)
SYSMEX CORPORATION
kakogawa 0000
JA  0000
Manufacturer (Section G)
SYSMEX AMERICA INC.
1-5-1 wakinohama-kaigandori
chuo-ku, kobe 651- 0073
JA   651-0073
Manufacturer Contact
peter shearstone, vp
577 aptakisic rd
lincolnshire, IL 60069-0000
2245439514
MDR Report Key3935842
MDR Text Key4532505
Report Number3009711478-2014-00016
Device Sequence Number1
Product Code GKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993299
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberCA-150
Device Catalogue Number99324114
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/28/2014
Initial Date FDA Received06/27/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2008
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
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