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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY CW4 ARTHROSCOPY PUMP ARTHROSCOPE

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ARTHREX, INC. SYNERGY CW4 ARTHROSCOPY PUMP ARTHROSCOPE Back to Search Results
Model Number SYNERGY CW4 ARTHROSCOPY PUMP
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Insufficient Information (4580)
Event Date 09/15/2021
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation. If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
Consigned cw4 pump used during an arthroscopic meniscal repair procedure. Pump started pumping fluid into the knee at a very rapid rate causing the pressure to rise in the patients knee. Nursing staff stopped the pump and turned it back on after a few seconds. Pumped work fine for a minute then started pumping fluid at a rapid rate again. From then onwards, they turned pump on and off manually to complete the procedure. The cw4 is consigned to crest hospital.
 
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Brand NameSYNERGY CW4 ARTHROSCOPY PUMP
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key12570649
MDR Text Key274694722
Report Number1220246-2021-03729
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K024291
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSYNERGY CW4 ARTHROSCOPY PUMP
Device Catalogue NumberAR-6485
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/04/2021 Patient Sequence Number: 1
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