MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 07/24/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

A user facility clinic manager reported a fresenius 2008k2 hemodialysis machine that sounded a false blood leak alarm due to a patient having methyl blue in their bloodstream on (b)(6) 2018.The patient could not be dialyzed, and was flown to a hospital, where they expired within 48 hours of (b)(6) 2018.The machine passed functional checks and returned to service without issue.Additional patient and machine information was requested, but was not provided.

Manufacturer Narrative

Patient information, added patient identifier, date of birth, sex, and weight.Clinical investigation.Added device manufacture date.Corrections: changed averse event to yes, changed product problem to no.Changed death to yes, hospitalization to yes.Changed date of event to (b)(6) 2018.Updated catalog number, serial number, and udi the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Manufacturer Narrative

Plant investigation: the machine was inspected by fresenius biomedical technician, and it passed all functional tests and returned to service without issue.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.

Manufacturer Narrative

Additional information: clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008k2 fresenius dialysis machine and an inability to initiate hemodialysis therapy due to a blood leak alarm resulting in delay of care.Causality for the false blood leak alarm was attributed to the patient receiving methylene blue during surgery due to right ventricular failure.It is likely the methylene blue caused a discoloration of the spent dialysate which triggered a false blood leak alarm; thus preventing the blood pump from engaging unless overridden.The blood leak detector functions by monitoring for discoloration in spent dialysate as it passes through a glass cuvette.When discolorations are noted, the blood leak detector will stop the blood pump.This is an intended design and may result in false blood leak alarms.It should be noted, no harm will result from the false blood leak alarm.Harms will be consequences of interruption of hd therapy while treating acute kidney injury patients and not as a result of device malfunction.It should be noted the patient expired approximately 48 hours after transfer, however the details surrounding the patient¿s death are unavailable.The patient¿s comorbid conditions prior to transfer included: endocarditis, renal failure, pulmonary hypertension, acute respiratory distress syndrome and metabolic acidosis.The patient was listed as critically ill prior to transfer to a tertiary care facility.Based on the information available, there is no allegation or evidence of an actual blood leak, machine malfunction or of the machine failing to perform as expected in relation to the event(s).Additionally there is no documentation or evidence the 2008k2 dialysis machine caused or contributed to a serious adverse event.

Event Description

Additional information - a patient was hospitalized on (b)(6) 2018 for complaints of fever, malaise, body aches, jaundice, nausea, vomiting, and weight loss for several days.The patient¿s medical history includes intravenous (iv) drug abuse and endocarditis, requiring an aortic valve (av) and mitral valve (mv) replacement in (b)(6) 2018.The patient had a recent relapse (details unknown).The patient vitals on admission were: temperature = 103.8, pulse = 120+, blood pressure = systolic - 90/diastolic - unknown, oxygen saturation = 92-97% on room air.The patient underwent abdominal/pelvis, head and chest computed tomography scans which showed bilateral lung apices, splenomegaly, and peri-portal edema within the liver.Blood cultures were positive for staphylococcus mitis, and the patient was treated with iv vancomycin and ceftriaxone.The patient continued to be severely anemic with worsening shortness of breath.The patient was placed on bipap and given lasix with improvement.The patient underwent a right heart catheterization, which showed elevated filling pressures, severe mitral regurgitation, and cardiogenic shock.A surgical replacement of the av/mv was decided.During surgery the patient required significant amounts of inotropic support for right ventricular failure; including iv epinephrine, vasopressin boluses and methylene blue (mb).Following surgery the patient was transferred to the cardiovascular icu and their condition worsened overnight requiring additional ventilator support, sedation and paralyzation.The patient was acidotic and receiving both iv and bolus bicarbonate.The patient required v-pacing for complete heart block and hemodialysis (hd) for marginal urine output and a rising creatinine level.An hd catheter (not a fresenius product) was surgically placed.While attempting to initiate hd, the 2008k2 dialysis machine incurred a ¿blood leak detected¿ alarm which could not be resolved.The medical staff surmised the mb given during surgery caused the false blood leak alarm to occur.The nephrologist decided to place the patient on continuous veno-venous hemofiltration, however there is no treatment data available for review.The patient was in hepato-renal failure with elevated liver function tests, and was given fresh frozen plasma, packed red blood cells and cryoprecipitate.The patient continued to require epinephrine, dopamine and norepinephrine for blood pressure support, and the decision was made to medical flight the patient to another hospital.Discharge diagnoses included endocarditis, renal failure, pulmonary hypertension, ards and metabolic acidosis.The patient was subsequently transferred to another hospital on (b)(6) 2018, where they expired approximately 48 hours later.

• Brand Name: 2008K2 MACHINE
• 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: 7864628
• MDR Text Key: 119829248
• Report Number: 2937457-2018-02670
• 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,Followup,Followup,Followup,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2010
• 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): Death; Hospitalization
• Patient Age: 34 YR
• Patient Weight: 78