MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008

Model Number CUSTOM COMBI SET

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

Patient Problem Death (1802)

Event Date 03/09/2015

Event Type  Death  

Event Description

During follow up on an unrelated event, the user facility's biomedical engineer reported that a pt coded during hemodialysis treatment.Medical records were received on (b)(6) 2015 and it was discovered that pt subsequently expired on (b)(6) 2015.Findings from the medical records: pt was admitted into the hosp on (b)(6) 2015 for questionable pulmonary embolism.While receiving intravenous contrast dye during a ct, the pt developed contrast-induced nephropathy which led to renal failure and he began hemodialysis.During his hospitalization, he had an amputation of part of his toes and foot from a pre-existing foot ulcer.Cultures from his foot revealed vancomycin resistant enterococcus (vre).It was further discovered he developed same in his bloodstream as well.His tunneled hemodialysis catheter was removed and a temporary dialysis catheter was placed.He was placed on intravenous antibiotics.He completed antibiotic treatment for his bloodstream infection and he was planned to have a tunnel catheter placed.However, on (b)(6) 2015, it was suspected the pt's infection had started again and was put on zosyn and zyvox.An infectious disease consult was ordered.Blood culture on (b)(6) 2015 confirmed pt had vre in the bloodstream.The pt was changed to daptomycin.The pt refused further amputation of the foot to further reduce recurrent enterococcal bacteria.On (b)(6) 2015 at approx 1400, the pt began to complaint of chest tightness and his blood pressure dropped to 68/35 with a heart rate of 71 during hemodialysis treatment.The ultrafiltration was turned off and 100cc of normal saline was administered.Bp monitor was recycled and read 90/47 with a heart rate of 71.His physician was at bedside and a stat ekg was ordered.Then, the heart rate dropped from 96 to 46.Dobutamine drip was ordered, the blood was returned and dialysis treatment was discontinued.Pt became non-responsive with no blood pressure and no pulse.Chest compressions were initiated, but it was discovered the pt was a do not resuscitate and chest compressions, as well as other life saving measures ceased.Pt was pronounced deceased at 1417.

Manufacturer Narrative

This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.Based on the info provided, it is unk how the device may have caused or contributed to the event.Medical records review: medical records were received and reviewed by post market surveillance clinical staff.It was noted that during the pt's hospitalization, the pt developed vre sepsis.The pt's vre never resolved and the pt started having episodes of hypotension during hemodialysis on (b)(6) 2015.During these episodes, the pt was unable to complete hemodialysis treatments due to his inability to maintain a systolic blood pressure of 90.There are no bicarbonate levels in the medical record for review.Medical records do not contain an autopsy or death certificate for review.The medical records do not show a causal relationship between the 2008k, the concomitant products or venofer used in the pt's hemodialysis treatment and the pt's death.Medical records do show that the pt's unresolved infection was a possible contributor to the hypotensive episodes during his hemodialysis treatments.A supplemental report will be submitted upon completion of the plaint's investigation.

• Brand Name: FRESENIUS COMBISET 2008
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas, cp 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4725988
• MDR Text Key: 18024553
• Report Number: 8030665-2015-00204
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CUSTOM COMBI SET
• Device Catalogue Number: 03-2722-6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NATURALYTE BICARB; NATURALYTE,; FESENIUS 2008K HEMODIALYSIS SYSTEM,; OPTIFLUX DIALYZER,
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Weight: 59