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

Model Number 104 H

Device Problem Fitting Problem (2183)

Patient Problem Nerve Damage (1979)

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 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 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
• Type of Device: WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
• Manufacturer (Section D): MAR COR PURIFICATION; 14550 28th avenue north; 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 Key: 7380079
• MDR Text Key: 103775232
• Report Number: 3019131-2018-00001
• Device Sequence Number: 1
• Product Code: FIP
• UDI-Device Identifier: 00817492020733
• UDI-Public: 00817492020733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• 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 Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 104 H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other