MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

Catalog Number 0500318E

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 08/01/2014

Event Type  Injury  

Event Description

A hemodialysis inpatient user facility reported that during treatment a blood leak occurred.The rn initiated treatment with immediate blood leak detected.Treatment was stopped and reset the lines and dialyzer.The leak was visually observed in the drain and the machine alarmed.Estimated blood loss was 100cc's.No damage was observed on the dialyzer but a slightly yellower color was observed at the ends of the dialyzer.Patient was able to complete treatment.Patient was stable prior to start of treatment and did not require intervention at the time of the incident; however, the patient did require an extra unit of blood to be transfused per md order due to the unexpected blood loss.Sample has not been returned to the manufacturer.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, 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.Medical records have been requested and have not been received by the manufacturer to date.Upon receipt of the medical records, a clinical investigation will be conducted and a supplemental report will be filed with the results of the clinical investigations.

• Brand Name: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; ogden UT
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4091257
• MDR Text Key: 18369436
• Report Number: 1713747-2014-00426
• Device Sequence Number: 1
• Product Code: FJI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: 0500318E
• Device Lot Number: 13HU02012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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
• Treatment: FRESENIUS 2008K MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR