MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS 2008K HOME

Catalog Number 190395

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

Patient Problem Loss of consciousness (2418)

Event Date 08/11/2012

Event Type  Injury  

Event Description

The pt's partner reported that he heard the pt call for help and he found her, unconscious, on the floor.The pt was transported to the hosp.The pt reported that on the day of event before beginning dialysis, she felt very tired, anxious, fatigued, and stressed.During dialysis, she began to feel like she was having a panic attack so she disconnected herself from the machine.The pt was treated for hypotension and blood pressure management.

Manufacturer Narrative

As per the clinical investigation from the fmc associate med dir, pt experienced an episode of loss of consciousness during her hemodialysis treatment at home during the first 44 minutes of treatment; she was transferred to the emergency room for med intervention after her helper called ems.No med records were provided.Hosp or physician contact/input was unavailable.The info provided is insufficient to draw an independent conclusion regarding the performance of equipment and supplies in relation to the serious injury of loss of consciousness.Based on the info reported, including the pt's past med history of seizures; and the investigation of the device, a device malfunction is unlikely since the pt continued using the same device without problems.Intradialytic hypotension is a well-known complications of hemodialysis, and it usually depends on therapy prescription, co-morbidities, and medications.The actual device was not returned for evaluation and therefore the reported event cannot be confirmed or replicated in field testing.An investigation of the device mfg records was conducted.Product labeling, material, and process controls were found to be within specifications.This is a retrospective mdr being submitted by fresenius med care as a remediation action committed to fda regarding all potential adverse events received between 21 march 2011 to 11 march 2013.

• Brand Name: FRESENIUS 2008K HOME
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA, WALNUT CREEK PLANT; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4044123
• MDR Text Key: 4724573
• Report Number: 2937457-2014-02137
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/11/2012

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: 190395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2012
• Initial Date FDA Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: DIALYZERS; BLOODLINES
• Patient Outcome(s): Hospitalization