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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAR COR PURIFICATION CWP 100 CENTRAL WATER TREATMENT SYSTEM WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
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MAR COR PURIFICATION CWP 100 CENTRAL WATER TREATMENT SYSTEM WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Back to Search Results
Model Number 104 H
Device Problem Fitting Problem (2183)
Patient Problem Abrasion (1689)
Event Date 02/28/2018
Event Type  Injury  
Manufacturer Narrative
A facility reported while a patient care technician was disconnecting the acid connections from the dialysis wall box used with their cwp 100 central water treatment system, the technician cut her hand on the dialysis chair after the connector fitting released. The technician did not need stitches and is reported to be doing fine. Mar cor regulatory affairs followed up with the facility's technical manager and he reported he has since trained the facility staff how to disconnect the connections from the wall boxes to avoid hitting their hands when the connection fitting releases. This complaint will continue being monitored in the mar cor purification complaint handling system.
 
Event Description
A facility reported while a patient care technician was disconnecting the acid connections from the dialysis wall box used with their cwp 100 central water treatment system, the technician cut her hand on the dialysis chair after the connector fitting released.
 
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Brand NameCWP 100 CENTRAL WATER TREATMENT SYSTEM
Type of DeviceWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Manufacturer (Section D)
MAR COR PURIFICATION
14550 28th ave. n.
plymouth MN 55447
Manufacturer (Section G)
MAR COR PURIFICATION
14550 28th ave. n.
plymouth MN 55447
Manufacturer Contact
alex nelson
14550 28th ave. n.
plymouth, MN 55447
7635094799
MDR Report Key7380115
MDR Text Key103774219
Report Number3019131-2018-00002
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number104 H
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/28/2018 Patient Sequence Number: 1
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