MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2622-3

Device Problem Occlusion Within Device (1423)

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.Manufacturing investigation: the device was not returned nor was a companion sample available to the manufacturer for physical evaluation.No malfunction was confirmed during evaluation of the alternate samples.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodline products from the reported catalog number (03-2622-3) shipped to this account within the selected time frame.A records review was performed on all identified lots.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

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.

• Brand Name: FRESENIUS COMBISET 2008
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 6000896
• MDR Text Key: 57057358
• Report Number: 8030665-2016-00536
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• 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
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2622-3
• Other Device ID Number: 00840861100231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2016
• 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 Weight: 80