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

Catalog Number 03-2962-3

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250); Use of Device Problem (1670)

Patient Problem Blood Loss (2597)

Event Date 09/12/2015

Event Type  malfunction  

Manufacturer Narrative

The blood lines were not returned to the manufacturer for physical evaluation and the plant investigation is on-going.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A user facility reported a patient experienced clotting within the blood lines of their home hemodialysis machine and conductivity alarms.This occurred approximately 2 hours into treatment.Due to the multitude of the clot, the patient was unable to have their blood returned from the lines.The patient was reported to have heparin induced thrombocytopenia, and therefore, could not increase the dosage of heparin in order to combat the clotting.Blood platelet level of 89,000 microl was reported.Patient's blood analysis concluded that the patient's kv/t was running around 1.4, therefore, the patient wasn't getting adequate dialysis.The patient's dialysis time was increased from 3:15/4 times a week to 3:30/4 times a week, but this did not improve the patient's kv/t.The patient did not exhibit any adverse symptoms or require medical intervention at any time.The patient had requested his previous home dialysis machine, and was provided with such.The clotting has not re-occurred to date.The reported machine was removed from service and was calibrated for conductivity.The home user facility has not put the machine back into service.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and field service was not requested; therefore, the failure mode cannot be confirmed.An investigation of the device manufacturing and labeling could not be completed as the lot number was not available.

• Brand Name: FRESENIUS K@HOME HEMO W/PRIME BAG
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; parque industrial reynosa; reynosa, tamaulipas, cp 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5250017
• MDR Text Key: 32262907
• Report Number: 8030665-2015-00549
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

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: Health Professional
• Device Catalogue Number: 03-2962-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 230