MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008T

Device Problems Alarm Not Visible (1022); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Hemodialysis clinic contact reported that when they were trying to administer iron through the venous port, the blood was coming out of the venous injection port.There was no reported patient complication.Patient did experience some blood loss, ~10cc.The dialysis treatment was discontinued.Follow up with the clinic indicates that the nurse felt that the dialysis machine was creating too much pressure which caused the leak.The dialysis machine was pulled from the floor and service was requested.Additional information was solicited.

Event Description

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Manufacturer Narrative

Correction: (b)(4).Plant investigation: no parts were returned to the manufacturer for physical evaluation.The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res).The res inspected the rollers, tubing guides, and tubing retainer/release, which were intact and functioning properly.The res verified pumping flow and verified that the tubing set could be removed and replaced multiple times without any issues.All functional checks passed.The unit is reportedly approved to be returned to service at the user facility.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances or any associated rework identified during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.The res verified that the machine was operating properly.Therefore, the complaint is not confirmed.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7462376
• MDR Text Key: 106718572
• Report Number: 2937457-2018-01156
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2008T
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1