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

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2014

Event Type  Injury  

Event Description

A home dialysis patient reported the machine was not supplying the correct amount of heparin the unit was set for at interval times.Follow-up with the patient's peritoneal dialysis (pd) nurse revealed the patient was bleeding extra and not clotting off due to an incorrect dosage of heparin being supplied to the patient during treatments.The nurse followed up with the patient and determined the patient was not properly trained on how to setup the machine for automated heparin dosages and had been providing manual doses of heparin, which was triggering the heparin pump alarms.The patient was re-trained on using the machine for heparin and upon visitation stated there was no issue with the machine.The patient has successfully completed treatments without further complications.The nurse confirmed the patient did not require hospitalization or medical intervention during this issue.

Manufacturer Narrative

Initial investigation findings to date indicate the reported alarm issue was attributed to manual application of heparin dosages by the patient.The report is being investigated by the manufacturer and has not yet been completed.A follow up mdr report will be filed upon completion of the investigation.

• Brand Name: 2008K @ HOME HEMODIALYSIS SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord plant; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3925474
• MDR Text Key: 4518367
• Report Number: 2937457-2014-01048
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/23/2014,05/22/2014

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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/22/2014
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• 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: SALINE; BLOOD LINES; HEPARIN; ACIDS; BICARBONATE
• Patient Outcome(s): Required Intervention