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

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

Patient Problem Unspecified Infection (1930)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

Plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.

Event Description

A hemodialysis pt reported being treated for an infection that persisted for over 3 weeks.Antibiotics was administered at the hospital to treat the infection.The at-home nurse revealed the pt has been on dialysis for approximately 5 years and is very meticulous about the treatment setup.The pt completes six treatments each week.Further info has been requested, however, no new details have been made available.Specific info pertaining to the type of infection or the relationship between the infection and the hemodialysis treatment has not been provided.

Manufacturer Narrative

The device was evaluated by the manufacturer.A visual examination of the blood pump rotor identified a missing ball bearing.The service documentation revealed that the blood pump rotor was replaced.Functional testing was performed which confirmed that the unit was operating properly.Following the service activity, the system was restored to full functionality.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.In addition, the dhr record review confirmed the labeling, material, and process controls were within specification.Although medical records were requested, none were received.Therefore, there is no way to confirm a causal relationship between the hemodialysis treatment using the k at home machine and the patient's infection.

• Brand Name: FRESENIUS 2008K @ HOME
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson street; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5247328
• MDR Text Key: 32103029
• Report Number: 2937457-2015-01641
• Device Sequence Number: 1
• Product Code: ONW
• UDI-Device Identifier: 00840861100958
• UDI-Public: 00840861100958
• Combination Product (y/n): N
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

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: 10/20/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• 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: 54 YR