MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K OLC ONLY WITH HEPARIN PUMP; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008K

Device Problem Pumping Problem (3016)

Patient Problem Chest Tightness/Pressure (2463)

Event Date 07/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No parts were returned to the manufacturer for physical evaluation.The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.Clinical investigation: the patient medical records were provided by the user facility on august 12, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.The patient has a significant medical history which includes the following: sigmoid colon cancer; non-st-elevation myocardial infarction (nstemi); pulmonary embolism (pe); paroxysmal afib; subdural hematoma (sdh); seizure; diabetes mellitus type 2; multinodular nontoxic goiter; end stage renal disease (esrd) with hemodialysis (hd) therapy.The pt takes a number of medications related to her comorbidities.Additionally, the patient's daughter noted that the patient requires two pillows to sleep at night due to orthopnea, which started two months ago.The summary for the diagnosis of acute respiratory failure with hypoxia state reads: ¿lung exam concerning for underlying lung pathology given continued rales at time of discharge despite normal oxygenation and pt subjectively baseline." the summary of ¿heart failure unspecified¿ reads patient's presentation highly suggestive of acute decompensated heart failure.Recent history of declining ejection fraction 45-50% in (b)(6) 2016, down from 56-60% in (b)(6) 2016 with echocardiography (echo) showing reduced right and left ventricular function, left ventricular hypertrophy (lvh), left atrial enlargement.Patient also presents with elevated brain natriuretic peptide (bnp) and worsening orthopnea.No machine alarms were reported during the hd treatment.However, it should be noted that a different patient underwent dialysis on the same machine, the same day, following this event.The machine was revealed to have had a faulty ultrafiltration pump, stroking 2.3 ml per 24 strokes, when it should be stroking 1 ml per 1 stroke.This event has been documented in a separate complaint file, and a separate mdr was submitted (ref.Manufacturer mdr id # 2937457-2016-00915).There is documentation in the medical record supporting a possible relationship between the hd machine and the patient¿s hypertensive emergency and flash edema episode which lead to the patient's presentation to the hospital emergency room (er) and subsequent hospital admission for care.However, there is also a possible association between the patient's co-morbid diseases and medications taken to treat those co-morbid diseases and the event.

Event Description

A report of an adverse event was reported to fmcna, llc by a nurse manager on (b)(6) 2016.The report pertains to an (b)(6), patient with end stage renal disease (esrd) receiving chronic in-center hemodialysis (hd) treatments.On (b)(6) 2016, the patient presented to the user facility for a routinely scheduled hd treatment.The hd therapy was initiated at 8:40 am.Treatment sheets note a consistent rise in the patient's blood pressure (bp) (high of 206/92) and pulse (high of 84) as the treatment progressed.At 11:15 am, approximately 2 hours and 35 minutes into treatment, the patient complained of not feeling well around the chest area, but denied having chest pain.The hd treatment was prematurely terminated, and then the patient was transferred to the hospital emergency room (er) by the medical emergency response team (mert).In the er, the patient was evaluated for sudden onset of shortness of breath (sob) with an elevated bp and chest discomfort/trouble breathing with pressure rated a 3-4 on a scale of 1-10.The patient received aspirin, furosemide, and metoprolol succinate orally, and at 12:10 pm, the patient was administered 0.4mg sublingual nitroglycerin.The patient was placed on a nitroglycerin drip at 12:37 pm with an order to titrate to a goal of systolic bp 160.At 3:47 pm, the patient's condition was noted as being improved so the nitroglycerin and supplemental oxygen were discontinued.The patient was admitted to the hospital with the diagnosis of hypertension emergency and flash pulmonary edema.While hospitalized, the patient continued to undergo scheduled hd treatments.The patient was discharged to home on (b)(6) 2016.On (b)(6) 2016, the patient presented to the user facility for her next routinely scheduled in-center hd treatment.The patient's current condition was noted as being well.

Manufacturer Narrative

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.No malfunction of the 2008k hemodialysis (hd) machine was alleged, observed or reported prior to, during, or following the treatment.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 deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the labeling, material, and process controls were within specification.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: 2008K OLC ONLY WITH HEPARIN PUMP
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5917294
• MDR Text Key: 53576059
• Report Number: 2937457-2016-00926
• 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
• Report Date: 11/17/2016

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: 2008K
• Device Catalogue Number: 190305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2008
• 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; Other; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 53