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 Hypervolemia (2664)

Event Date 03/14/2017

Event Type  Injury  

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 march 14, 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 4kg of weight post hd treatment.The patient required an extra hd treatment the following day.However, no other adverse events were experienced.

Event Description

A biomedical technician (biomed) 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), (a total weight gain of 5.3kg over estimated dry weight), the vital signs (vs) were stable, blood pressure (bp) sitting 129/84, bp standing 149/91, pulse 80 and regular, respirations 20, and temperature 98°f prior to the start of hd treatment.At the initiation of hd treatment, the patient was reportedly alert and denied complaints, bp 134/83, pulse 71.The hd treatment continued as expected with no patient adverse event, no reported machine alarms or malfunction through the completion of hd treatment.Post hd treatment, the vs were stable, bp sitting 120/84, bp standing 134/94, pulse 73 and regular, respirations 19, temperature 98.6°f.The patient¿s post hd treatment weight was (b)(6), which was a total of a 1.2kg weight reduction.However, the expected weight reduction was 5kg.The net uf removed (as recorded on the 2008k2 machine) was 5201ml, was a discrepancy of 4kg of weight.It was reported that the machine¿s uf had not been turned off during hd treatment and 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 returned to the clinic the next day for an extra hd treatment.No other adverse events were experienced.The 2008k2 hd machine was removed from service for evaluation by the biomed.The biomed stated that the machine will remain 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: 6548707
• MDR Text Key: 74581762
• Report Number: 2937457-2017-00331
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/07/2017
• Initial Date FDA Received: 05/05/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 145