MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS K @ HOME HEMO WITH PRIME BAG

Catalog Number 03-2962-3

Device Problems Fluid/Blood Leak (1250); Mechanical Jam (2983)

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

Event Date 10/01/2015

Event Type  malfunction  

Event Description

A patient reported that approximately four hours into the dialysis treatment, the machine experienced an air detect alarm.The patient noted that the combiset tubing became bunched up within the rotor segment of the blood pump.The patient was not able to dislodge the tubing from the rotor segment which resulted in the loss of a full circuit of blood.The estimated blood loss (ebl) is 500cc which is an approximation of blood that remained in the dialyzer and lines could not be returned to the patient.The patient was switched to another machine with a new setup to continue and complete treatment without any further issues.There were no patient complications as a result of this event and no medical intervention was required.Follow up information was provided by the at-home nurse who revealed that the patient has been on dialysis for approximately 5 years and is very meticulous with the setup.Additionally, the nurse confirmed that the patient had followed proper procedure when the bloodline was inserted into the blood pump segment.The actual sample is not available for evaluation.Further information has been requested.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore, the failure mode cannot be confirmed.However, a records review was performed on the reported lot.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 batch record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: FRESENIUS K @ HOME HEMO WITH PRIME BAG
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; parque industrial reynosa; cd, reynosa, tamps ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 0245 ; 8006621237
• MDR Report Key: 5249564
• MDR Text Key: 32114032
• Report Number: 8030665-2015-00545
• Device Sequence Number: 0
• Product Code: ONW
• 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
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 04/01/2018
• Device Catalogue Number: 03-2962-3
• Device Lot Number: 15DR01239
• 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: 04/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR