MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET

Catalog Number 03-2722-9

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

Patient Problems Death (1802); Blood Loss (2597)

Event Date 07/13/2015

Event Type  Death  

Manufacturer Narrative

The sample has not been returned to the manufacturer.No further patient information is available.The plant investigation is in progress.A supplemental medwatch will be submitted when new information becomes available.

Event Description

Information was received from a fresenius employee after reading a newspaper article which referenced a patient's death.This story was reported in three separate news reports.It was reported the patient was on hemodialysis treatment when her, "arterial blood line was disconnected from her heart catheter and wasn't noticed by the staff for an unspecified amount of time." the patient lost a lot of blood and died a short time later at the hospital.No other information is available.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the 3 months prior to the reported event date.A companion sample from one of the lots was able to be returned for investigation and no defects were noted.In addition, 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.Device history review was performed on the potential related lots.No nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met current specifications.The component history files of the patient end connector were also reviewed and no nonconformance reports, deviations, or re-works were found.During the investigation, it was found that there is some inconsistency in the report which states that "arterial" end of the bloodline was disconnected from the catheter with a high volume of blood loss.This scenario may result in some blood loss from the disconnected "arterial" port of the catheter but such loss is usually minimal because the hemodialysis catheters are placed in the low pressure venous system.Furthermore, the dialysis machine will alarm immediately either due to high pre-pump arterial pressure or due to a drop in blood level in the extra-corporeal circuit.The volume of the extracorporeal circuit is approximately 150-250ml and at a typical blood flow rate of 350-400ml/min, it will take less than one minute to trigger the blood level detector alarm.Blood leak from the disconnected "arterial" end of the catheter for this duration is un-likely to result in life-threatening blood loss.Based on the provided info that there was significant blood loss, it is most likely that the disconnection occurred at the venous port of the dialysis catheter.In this case, the blood pump may continue to pump blood through the venous end of the bloodline leading to exsanguination.Although requested, medical records were not received.

• Brand Name: CUSTOM COMBI SET
• 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
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5022199
• MDR Text Key: 23938159
• Report Number: 8030665-2015-00375
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR