MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA HOME HEMO COMBI SET

Catalog Number 03-2962-3

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

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

Event Date 07/06/2015

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 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

Results of the clinical investigation are as follows: based on the 36 pages of medical records information it appears that on (b)(6) 2015, this (b)(6) male patient was admitted into the hospital with shortness of breath.There are no admitting diagnoses for this event but, the patient was found to have dyspnea, hypertension, with ischemia and other cardiac etiology possible.The patient was admitted to the medical floor.Medical records state the patient was due for dialysis on (b)(6) 2015 but, did not receive it he had a previous admission on (b)(6) 2015 for shortness of breath and the patient was found to be acutely fluid overloaded, however, there was no evidence of fluid overload found during the (b)(6) 2015 admission.According to the hemodialysis registered nurse, these hospitalizations had nothing to do with product malfunctions.There is no documentation in the medical record that indicates a causal relationship between the patient's 2008k at home machine or concomitant hemodialysis products and the patient's shortness of breath.There was no evidence of pyrogen reaction or fever.Medical records reveal the patient has a history of cardiac issues which in addition to small pleural effusions were likely contributors to the patient's dyspnea.The device was not returned to the manufacturer for physical evaluation.The customer was unable to provide the manufacturer with the lot number of the home hemo combiset used in the reported event.As no lot number was provided by the complainant, a record review was performed on each of the lot numbers shipped to the complainant in the three months leading up to the reported event.The batch production records for these lots were reviewed.The batch records confirmed that released product met specifications; and documented manufacturing process controls were within specifications.Per the documented product investigation, there was no indication that the fresenius optiflux dialyzer caused, contributed to or was a factor in the reported event.

Event Description

The following is from medical records provided by the patient's treatment facility.The patient presented to the hospital with dyspnea.The patient stated that the dyspnea on exertion had been increasing over the previous week.He received lasix intravenously.A computed tomography angiography (cta) revealed small bilateral pleural effusions but no edema.

• Brand Name: HOME HEMO COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA ; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; parque industrial reynosa ; cd, reynosa, tamps ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street ; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5197124
• MDR Text Key: 30325302
• Report Number: 8030665-2015-00492
• 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 Catalogue Number: 03-2962-3
• 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: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 102