MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K MACHINIE, SHORT CAB, OLC/DIASAFE P, HP

Device Problem Misassembly by Users (3133)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/31/2015

Event Type  malfunction  

Event Description

A report was received in fresenius medical care (b)(4) from a dialysis clinic director that a home hemodialysis patient contacted his nurse to notify her that there seemed to be some issue with his machine.The patient had attempted to reach technical support reportedly because when emptying the dialyzer, water was coming out of the red connector instead of the blue connector.The nurse did a home visit and she found that the red and blue dialysate connectors were reversed.According to the nurse, the patient had a total of 6 treatments with the reversed connectors.The biomedical tech visited the patient' home on (b)(6) 2015 and changed the connectors back to the correct positions.The patient had blood drawn on (b)(6) 2015 and was advised to perform a home hemodialysis treatment that evening, due to inefficient dialysis.The patient experienced additional machine alarms and was unable to dialyze at home that evening.He reportedly received a dialysis treatment at the home hemodialysis unit in the hospital.Upon follow up with fmcc, it was confirmed the patient was not admitted to the hospital and is continuing on home hemodialysis and doing well.It was additionally learned, that this machine had been refurbished prior to being delivered to patient.At that time, the dialyzer connectors were reportedly reversed and installed on the incorrect lines, arterial connector to venous dialysate line and venous connector to arterial dialysate line.

Manufacturer Narrative

The plant investigation is in process.A supplemental medwatch will be submitted upon completion.

• Brand Name: 2008K MACHINIE, SHORT CAB, OLC/DIASAFE P, HP
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st; waltham, MA 02451
• MDR Report Key: 4597579
• MDR Text Key: 16459559
• Report Number: 2937457-2015-00323
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2007
• 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