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 Problem Inadequate Ultra Filtration (1656)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2018

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 user facility clinical manager reported that the ultrafiltration (uf) goal and treatment time changed on a fresenius 2008k2 hemodialysis (hd) machine 7 minutes before the end of the patient's treatment.The machine was programed to a uf goal of 300ml, however, 7 minutes before the end of the patient¿s treatment, it was noted that the machine defaulted to a uf goal of 200ml.The clinical manager stated that the machine was manually adjusted back to the original settings using the up/down arrows to adjust the uf goal and treatment time.The uf was not turned off at all during treatment.It is unknown if the up/down arrow keys were used to program the initial setting.The patient was able to successfully complete treatment on the machine and the correct amount of fluid was removed from the patient at the end of treatment.The patient¿s pre- and post-treatment weights were as expected and the same scale was used for both readings.The patient did not eat or drink at all during treatment and no additional fluids were provided to the patient.There was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient did not have any complaints or symptoms related to the reported event and no additional treatments were required.Additional patient and treatment details were not provided.Per the clinical manager, the machine was returned to service and no parts were replaced or machine repairs made.

Manufacturer Narrative

Correction: upon further investigation, it was determined that the event reported on this mdr is not a reportable event.There will be no further updates on mfr.

• 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: 8189107
• MDR Text Key: 131145981
• Report Number: 2937457-2018-03718
• Device Sequence Number: 1
• Product Code: KDI
• 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
• Report Date: 01/16/2019

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?: No
• Device Age: MO
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1