MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008K

Device Problem Pumping Problem (3016)

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

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Note: epogen is routinely administered to help correct anemia of end stage renal disease (esrd) patients on hemodialysis (hd) to reduce the need for red blood cell transfusions.It is not indicated for use in patients who need an immediate blood transfusion since the medications effects on the increased production of red blood cells will take anywhere between approximately 2-6 weeks.The patient had been receiving the medication prior to the event based on the most current hemoglobin level.The use of epogen and the dose administered is titrated up or down as necessary until the target hemoglobin level is achieved.No parts were returned to the manufacturer for physical evaluation.The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of the activity.

Event Description

A user facility reported that the blood within the extracorporeal circuit clotted while a patient was undergoing a routinely scheduled hemodialysis (hd) treatment.The blood pump continued pumping, however, the blood had clotted, and therefore, failed to circulate through the circuit.No machine alarms were generated.The patient was using heparin during the hd therapy with the initial setup.The extracorporeal circuit was discarded, and the patient was re-strung on the same machine.The patient's estimated blood loss (ebl) from the initial setup being discarded was noted as being approximately 400ml.The hd treatment was continued on the same machine, with a new setup, however, the blood lines clotted once again.No machine alarms were generated.Once again, it was noted that the patient was using heparin.This patient's estimated blood loss from the second extracorporeal circuit being discarded was noted as being approximately 400ml.The patient was then restrung on a new machine with new supplies.The hd treatment was continued and was able to be successfully completed with no further issues occurring.The patient experienced hypotension at the end of the treatment, which the nurse attributed to the blood loss.The patient was administered additional epogen, but did not require any medical intervention.No other patient adverse effects were experienced.The user facility indicated that the blood pump worked properly and never stopped, however, the blood failed to circulate through the lines.Following the event, the unit was pulled from service.Although follow-up information was received which revealed that the machine has been returned to service at the user facility with no further issues being reported, it was noted that no evaluation was performed by the on-site biomedical technician.The disposable bloodlines were not available to be returned to the manufacturer for evaluation as both were discarded by the user facility.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.Follow-up information was provided by the biomed at the user facility who revealed that the reported issue was not duplicated after removing the unit from service and testing.Functional testing performed by the biomedical engineer confirmed the unit was operating properly.The unit has been returned to service at the user facility without a recurrence of the event as reported.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the labeling, material, and process controls were within specification.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 6000884
• MDR Text Key: 56551093
• Report Number: 2937457-2016-01077
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

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 Model Number: 2008K
• Device Catalogue Number: 190371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2008
• 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
• Patient Weight: 80