MAUDE Adverse Event Report: MAR COR PURIFICATION CWP 100 CENTRAL WATER TREATMENT SYSTEM; WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Model Number	104 H
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional 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 connector fitting released and the technician's hand hit the base of the wall box causing nerve damage in his hand.The technician was reported to be out of work for one week as a result of the reported hand injury.Mar cor regulatory affairs followed up with the facility's technical manager and he reported he has trained the facility staff how to disconnect the connections from the wallboxes to avoid hitting their hands when the connection fitting releases.The injured employee is reported to be back at work and is doing fine.This complaint will continue being monitored in the mar cor purification complaint handling system.
Event or Problem 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 hit his hand on the base of the wall box, causing nerve damage in his hand.The technician was reported to be out of work for one week as a result of the reported hand injury.

• Brand Name: CWP 100 CENTRAL WATER TREATMENT SYSTEM
• Common Device Name: WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
• Manufacturer (Section D): MAR COR PURIFICATION; 14550 28th avenue north; plymouth MN 55447
• MDR Report Key: 7380079
• Report Number: 3019131-2018-00001
• Device Sequence Number: 1097663
• Product Code: FIP
• UDI-Device Identifier: 00817492020733
• UDI-Public: 00817492020733
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K974899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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
• Operator of Device: Other
• Device Model Number: 104 H
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other