MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

Device Problems Backflow (1064); Suction Problem (2170)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had a saline bag backfill during a patient treatment.The backfill was visually observed.The biomed did not report that there were any machine alarms.A patient was connected to the machine at the time of the incident, and their treatment ended 30 minutes earlier than scheduled due to the issue.There was an estimated blood loss of 30ml to the patient.The patient complaint of pain in their hand when the issue occurred.It was later confirmed with the nurse present at the event that there was no injury, adverse event, or medical intervention as a result of the incident.The biomed reported that there was a quick disconnect on the drain line and that the drain line length and height were within specification.The biomed believes the saline bag backfill was due to user error.It was confirmed that the unit has received the cbe hardware and software upgrades.The biomed tested the machine and the issue was not able to be duplicated.The machine is back in service without reoccurrence of the reported event.

Manufacturer Narrative

Correction: patient code updated to blood loss.Device code updated to suction problem.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Additional information: a fresenius regional equipment specialist (res) inspected the machine at the user facility.The res verified the voltage of the air separator on the distribution board.The res verified the water pressures and deaeration pressures were within specifications.The res visually inspected the high flow regulator for leaks or concentrate build up and saw no signs of either.The res noted a leak on the bicarb pump, as well as pinched tubing on valve 29, and a concentrate crust buildup on the acid and bicarb port.The res advised the user facility to repair the leak, remove the pinch from the tubing, and replace the acid and bicarb ports.The res confirmed the machine passed functional tests.

Manufacturer Narrative

Plant investigation: a fresenius regional equipment specialist (res) perform an onsite inspection regarding the backfill issue.The res could not duplicate the saline backfill.The machine passed functional checks and is back in service with no recurrence of the reported event.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 related to 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.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: 8334760
• MDR Text Key: 136864904
• Report Number: 2937457-2019-00477
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/11/2019

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 Catalogue Number: 190610
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 02/20/2019; 02/26/2019; 03/07/2019
• Supplement Dates FDA Received: 02/22/2019; 02/27/2019; 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 77