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 Problems High Blood Pressure/ Hypertension (1908); Loss of consciousness (2418)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation: no parts were returned to the manufacturer for physical evaluation.The 2008k2 hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res) due to the reported event.The res performed the uf problem identification procedure with the customer and the machine failed the uf balance error portion of the checklist.The volume removed from the simulated patient was 940 ml (found by subtracting what was left in 2000 ml cylinder after one hour).The uf output collected in our other cylinder was 1004 ml, a difference of 64.The maximum allowable error per procedure is 30 ml.The machine passed all other tests.Functional checks were performed.Per the biomedical technician (biomed) at the facility, the machine has been removed from service permanently.A records review was performed on the reported device 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 related to the reported event.Additionally, a review of the device history record (dhr) confirmed the results of the in-progress and final quality control (qc) testing met all the requirements.Clinical investigation: there is documentation to show a causal relationship between the patient event of excess fluid removal resulting in subsequent hypertension and loss of consciousness with hospitalization and the fresenius 2008k2 hemodialysis machine.The machine evaluation found that the ultrafiltration (uf) balance error failed testing during the uf problem identification procedure.

Event Description

A user facility reported that a patient became unresponsive during their hemodialysis (hd) treatment.Per the facility, too much fluid was removed during their treatment, resulting in the patient being hospitalized.The patient was initiated on hd therapy at approximately 16:12 hours on (b)(6) 2018.The patient was alert and oriented with no reported issues.No patient pre-treatment vital signs were provided.At approximately 17:05 hours, the patient had no response to stimuli for 30 seconds.Treatment was stopped at 17:07 hours and the patient blood was returned (volume unknown).A rapid response was called (unknown if any intervention given) and the patient subsequently was awake and alert but slow to respond.Patient blood pressure was 186/91 at this time.It is unknown at what point the patient was transported to the hospital.Hospital course and patient disposition is unknown.Per the facility, the 2008k2 machine ultrafiltration (uf) volume calibration revealed it was removing 0.3ml more than it was supposed to per stroke (total volume unknown).The machine was removed from service and a fresenius regional equipment specialist (res) evaluated the machine.The uf problem identification procedure was performed and the machine failed the uf balance error portion of the checklist.Per the res, all other tests passed.The biomedical technician at the customer location stated the machine has been removed from service permanently.

• 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: 7470549
• MDR Text Key: 106832868
• Report Number: 2937457-2018-01176
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2011
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 89