MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K HOME MACHINE SHOT CAB OLC DP HP

Device Problem Mechanical Problem (1384)

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

Event Date 09/30/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment a home hemodialysis patient encountered an alarm that he could not clear.The pt was very groggy due to sleeping pill and wasn't able to determine the exact alarm.The pt did not complete treatment.Estimated blood loss was 300 cc due to blood in lines when pt disconnected.The pt had no adverse effects and no med intervention was required.

Manufacturer Narrative

Plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

The device investigation and repair were performed in the field service technician.The blood pump module and single needle module were replaced and the replacement modules were calibrated.The field service technician performed a simulated treatment after replacing and calibrating the modules.The machine passed subsequent testing.The pump switching occurred at proper pressures.All issues were resolved during the field service investigation.The patient remembers the word "feedback" "bp feedback error" is the only message that contains the word "feedback".The level in the single needle chamber rose upwards through the tubing leading towards the single needle pressure sensor and the venous pressure which is typically 330 was 200 and it slowly dropped to a lower value.The patient could not return the blood in the circuit because he could not raise the pressure to switch on the single needle pump.The patient had taken a sleeping aid that evening.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: 2008K HOME MACHINE SHOT CAB OLC DP HP
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: dianne chin ; 920 winter st; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4230704
• MDR Text Key: 4999451
• Report Number: 2937457-2014-03022
• 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: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• 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?: No
• Date Manufacturer Received: 10/07/2015
• 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