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

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

Patient Problems Anemia (1706); Pleural Effusion (2010)

Event Date 06/29/2015

Event Type  Injury  

Manufacturer Narrative

Medical records and treatment info have been requested.This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.A supplemental report will be submitted upon completion of the investigation.

Event Description

A hemodialysis pt reported he was hospitalized.No other info was given at the time.Upon follow up with the pt he reported the he was hospitalized (b)(6) 2015 through (b)(6) 2015 for shortness of breath during hemodialysis.Follow up with the home therapies registered nurse (htrn) was performed for more info.According to the htrn, the hospitalization was due to pleural effusion and anemia and was not related to a product malfunction.The pt continues on home hemodialysis without issue.

Manufacturer Narrative

The patient was found to be in acute fluid overload.The medical records show that the home patient had hemodialysis on (b)(6) 2015 w/no complications.Dialysis treatment sheets are not available for (b)(6) 2015.Although, according to the patient's wife, the patient was hospitalized for shortness of breath during dialysis on (b)(6) 2015, there is no mention in the medical record that patient was receiving hemodialysis when he became short of breath.In addition, hemodialysis treatment sheets for (b)(6) 2015 state, "patient was dialyzed on (b)(6) 2015 in the hospital." according to the hemodialysis registered nurse (hdrn), the hospitalizations had nothing to do with product malfunctions.Medical records dod not contain progress notes, physician orders, medication lists or history and physical for review.Medical records suggest that the cause of the shortness of breath was fluid overload that was likely secondary to either malignant hypertension or change in dry weight.There is no documentation in the medical record that indicates a causal relationship between the patient's 2008k at home machine or concomitant products and the patient's shortness of breath.Although the patient was exposed to recalled bicarbonate, there is no mention in the medical record related to pyrogen reaction which is allegedly associated w/exposure to the recalled bicarbonate.The device was not returned to the manufacturer for investigation.No device evaluation was performed; no alleged malfunction of device.All device history records were reviewed and released according to review and release procedures.The system level review of the device and concomitant products found no indication that the products caused or contributed to the event.

Event Description

From medical records: the patient is an (b)(6) male with a history of hypertension anemia, obstructive sleep apnea on nocturnal cpap, and end stage renal disease.The patient presented to the hospital with shortness of breath.The patient was admitted with an acute episode of fluid overload, likely secondary to either malign an t hypertension or chan ge in dry weight.The fluid was taken off with dialysis and was stable overnight and discharged the next day.

• Brand Name: 2008K AT HOME MACHINE, SHORT CAB, OLC/DP, HP
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): CONCORD PLANT, FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave. ; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street ; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5197123
• MDR Text Key: 30326017
• Report Number: 2937457-2015-01552
• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 10/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 101