MAUDE Adverse Event Report: CONCORD MFG FRESENIUS 200K@HOME

Catalog Number 2K0S174114

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

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

Event Date 02/09/2014

Event Type  malfunction  

Event Description

A hemodialysis patient reported during treatment a blood leak occurred.Home patient reported to fresenius canada staff that he has lost a circuit of blood (approx.300ml).He reports that he wakes up in the middle of the night and finds the venous pressure is zero and machine will not run his blood.He also stated that the venous chamber level was rising throughout the night.The 2008k at home machine was checked and found to be okay.Patient had no adverse effects and required no medical intervention.Machine has not been returned to the mfr.

Manufacturer Narrative

The plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.This medwatch report is associated with mdr report numbers: 8030665-2014-00220, 00221, 00222, 2937457-2014-00378, 00379 and 00380.

• Brand Name: FRESENIUS 200K@HOME
• Manufacturer (Section D): CONCORD MFG; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: jennifer nabukenya ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3721067
• MDR Text Key: 4233922
• Report Number: 2937457-2014-00380
• 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: Foreign,Consumer,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2K0S174114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2014
• Initial Date FDA Received: 03/12/2014
• 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: SINGLE NEEDLE BLOOD TUBING SET