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

Model Number 2008K2

Device Problems Filtration Problem (2941); Pumping Problem (3016)

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

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturer investigation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.Attempts to gather additional event related information have been unsuccessful.Therefore, the current repair status of the machine is unknown.The unit has remained out of service since (b)(6) 2017 and the biomed has indicated that on-site service by a fresenius res will be performed following approval of the po request by the user facility¿s compliance officer.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 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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Clinical investigation: there is an allegation against the 2008k2 machine stating that the uf control function failed and the documentation in the medical records indicated that there was a possible causal relationship between the 2008k2 machine and the subsequent discrepancy of 2.2kg of weight gain post hd treatment.The patient experienced no adverse events and no medical intervention was required.

Event Description

A nurse at a user facility reported that the 2008k2 hemodialysis (hd) machine ultrafiltration (uf) pump was not removing the proper amount of fluid during a patient¿s hd treatment.The patient¿s pre-weight was (b)(6) kg), which was noted as being 2kg over the estimated dry weight (edw).At the initiation of hd treatment, the patient was reportedly alert and denied complaints.The patient was initially hypertensive, but became normal after approximately thirty (30) minutes into treatment (bp 141/81) and remained normotensive and reportedly comfortable throughout the hd treatment.The hd treatment continued as expected with no patient adverse event and no reported machine alarms or malfunction until the hd treatment was completed.The patient¿s post hd treatment weight was 101.2kg, which was a total of a 2.2kg weight gain.However, the expected weight reduction was 2.3kg from the pre hd treatment weight of 99kg.The net uf removed (as recorded on the 2008k2 machine) was 2300ml, in which a discrepancy of 2.2kg of weight gain exists.It was reported that the machine¿s uf had not been turned off during hd treatment and that the patient did not eat or drink during hd treatment.It was further reported that the patient was weighed standing by the staff and that the facility¿s scale is calibrated and working without issue.The 2008k2 machine passed all machine setup functions.The patient did not experience any adverse effects and no medical intervention was required.Additionally, the patient¿s spkt/v (measurement of clearance of urea) recorded for the hd treatment was 1.69, with the standard of adequate dialysis is at a minimum kt/v of 1.2.The 2008k2 hd machine was removed from service for evaluation by the biomed.The biomed did not provide specific information on the machine status but indicated that at some point in time during troubleshooting, the diasafe filter and balancing chamber membranes were replaced and the machine was but back into service.Currently, the machine remains out of service pending on-site evaluation by a fresenius regional equipment specialist (res).No further information has been made available.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6560510
• MDR Text Key: 75014861
• Report Number: 2937457-2017-00355
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2017

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: 2008K2
• Device Catalogue Number: 190610
• Other Device ID Number: 00840861100859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OPTIFLUX 180NRE DIALYZER ASSEMBLY
• Patient Age: 59 YR
• Patient Weight: 97