MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K @ HOME MACHINE, SHORT CAB, OLC/DP, HP

Model Number K@HOME

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

Patient Problems Syncope (1610); Low Blood Pressure/ Hypotension (1914)

Event Date 07/10/2015

Event Type  Injury  

Manufacturer Narrative

Patient medical records have been received and are being reviewed by the post market surveillance clinical staff.A supplemental report will be filed upon completion of medical record review and plant investigation.

Event Description

A hemodialysis patient reported he lost consciousness on (b)(6) 2015 and was taken to the hospital.He was discharged on (b)(6) 2015.The patient had not dialyzed on that day.Findings for the medical records: reason for hospitalization: syncopal episode.The patient had been discharged from the hospital on (b)(6) 2015 for shortness of breath.He was placed on new blood pressure meds at the time of his discharge.On (b)(6) 2015, the patient stood up from his recliner and suddenly passed out.Ems report: blood pressure was 100/60, pulse 70, saturating 100% on supplemental oxygen and glucose was 87.Patient was admitted to hospital likely from orthostatic hypotension.His antihypertensive medications were adjusted.The patient was due for dialysis on (b)(6) 2015, but hospital did not dialyze patient as he could have been hypovolemic at the time.Condition on discharge: improved and stable.The patient remained orthostatic, but not symptomatic and currently doing well.

Manufacturer Narrative

Device review: the patient did not request a service call for the reported event.The device was not returned to the manufacturer for failure analysis.A device history record review was performed and the device was found to have been manufactured per specifications.Medical record review: medical records were received and reviewed by post market surveillance clinical staff.It was noted that there was no documentation in the medical record supporting a possible association between the k@home and the event on syncope.At the time of this review, there was no clinical information that could allow us to analyze a temporal association between the episode of syncope and the hemodialysis process, due to the fact that the patient was not dialyzing at or four hours prior to the time of the event.However, there was an association between the event the patient's concomitant use of antihypertensive medications.Review of this case does not change the current benefit-risk for k@home hemodialysis machine.Further information has been solicited.

Event Description

Additional information from medical records: (b)(6) year old male with end stage renal disease on hemodialysis therapy dialyzing at home on monday, wednesday, friday schedule.On (b)(6) 2015, the patient presented to a emergency department with complaints of dyspnea on exertion and some degree of dyspnea at rest that had been occurring for the past week.He was transferred and admitted to another hospital.The patient's physical examination on (b)(6) 2015 revealed a blood pressure of 199/83, heart rate and rhythm regular with a load and high pitched holosystolic murmur v/vi, most audible at the apex without gallops or rugs, lung sounds clear to auscultation.On (b)(6) 2015, the patient was administered 100mg of lasix via intravenous route, with 300ml of urinary output.He stated that dialysis does not improve his symptoms, he was compliant with his renal diet and fluid restrictions and had been at his dry weight for the past two weeks.On (b)(6) 2015, the patient was discharged from the hospital with multiple blood pressure medications, including lasix, aldactone, coreg, and lisinopril.While at home on (b)(6) 2015, the patient stood up from a sitting position, experienced syncope, lost consciousness and fell to the floor without hitting his head or acquiring any fractures.On (b)(6) 2015, emergency medical services was called and transported the patient to an emergency department.

• Brand Name: 2008K @ HOME MACHINE, SHORT CAB, OLC/DP, HP
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS USA INC; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5207265
• MDR Text Key: 30641568
• Report Number: 2937457-2015-01568
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2015

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: K@HOME
• Device Catalogue Number: 1930395
• Other Device ID Number: 00840861100958
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FOSRENOL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 105