MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008, NO HEPARIN LINE

Model Number 03-2742-9

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

Patient Problem Cardiac Arrest (1762)

Event Date 07/10/2015

Event Type  Injury  

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.Partial medical records have been received and are being reviewed by post market surveillance clinical staff.Additional medical records have been requested.Device eval: the actual sample was received and evaluated, during the eval no issue or defects were found.A visual inspection was performed and the device was found to be in good condition.A functional test was performed to the actual sample.The sample tested worked as intended without any abnormalities during the tested period.

Event Description

The user facility reported that pt presented to dialysis with complaints of abdominal/bladder pain.A call was placed to his nephrologist by the nursing staff and permission to start treatment was obtained.Approximately one hour and seven minutes into the pt's hemodialysis treatment, the pt was found unresponsive without a pulse and cyanotic lips at 17:30.The pt was making a "gurgling" sound.Cpr was initiated at 17:30 and oxygen was provided at 10 l/minute.Aed shock was applied at 17:32 and 17:36.Dialysis treatment was discontinued at 17:30, extracorporeal circuit was returned.Total iv fluids delivered 1400ml normal saline solution.Ems was notified and assumed care at 17:40.Pt was transferred from facility at 17:45.The clinic manager reported that pt was new to dialysis and was not ordered to have any fluid removed.They were "running him even".Pt's blood pressure at 17:26 was 124/68.The pt was admitted to the hospital on (b)(6) 2015 and is still admitted.The pt was reportedly doing better on a regular med surgical floor and has not been discharged yet.There was no device malfunction alleged.Functional testing of the device was performed post event and the device passed all tests.

Manufacturer Narrative

Medical record review: medical records were received and reviewed by post market surveillance clinical staff.It was noted that patient had a prior hospitalization on (b)(6) 2015 for abdominal pain, a 50 pound weight gain and was admitted for constipation and uremia.Discharge diagnoses, progress notes and diagnostic tests are not available for the (b)(6) 2015 hospital admission.Medical records reveal patient received hemodialysis on (b)(6) 2015 with adverse events.Medical records do not include hospital lab/diagnostic results, progress notes, physician orders, diagnoses or treatment records for review.There is no documentation in the medical record that indicates a causal relationship between the patient's hemodialysis treatment and the patient's unresponsive episode.

Event Description

Findings from medical records: patient presented at hemodialysis treatment on (b)(6) 2015 and arrived in stable condition.Patient informed nursing staff that he had a groin pain on urination and coughing.Patient's predialysis vital signs were as follows: bp 136/86, pulse 93, respirations 18 and temperature 97.4.Patient's dialysis was accessed through his right jugular tunneled catheter and began at 16.20.At 17:28, the patient's vitals were are follows: blood pressure palpated at 40, pulse 20, respirations 5, 4 temperature 93.6.Hemodialysis orders: optiflux 200nzre, olc-v.45.33.Manual 800ml/min.Dialysate composition: 3.0k, 2.25 ca, 1.0 mg, 100 dextrose.Sodium 137.Bicarb machine setting 35: blood flow rate 350, scheduled hours 4:0.Blood volume processed: 84 estimated dry weight 120 kgs.Vitamin d oral.

Manufacturer Narrative

Medical records reveal patient received hemodialysis on (b)(6) 2015 without adverse events.Medical records do not include hospital lab/diagnostic results, progress notes, physician orders, diagnoses or treatment records for review.There is no documentation in the medical record that indicates a causal relationship between the patient's hemodialysis treatment and the patient's unresponsive episode.

• Brand Name: FRESENIUS COMBISET 2008, NO HEPARIN LINE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa ; cd, reynosa, tamps 88780 ; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 7816999000
• MDR Report Key: 5010246
• MDR Text Key: 23388326
• Report Number: 8030665-2015-00363
• 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,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup,Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03-2742-9
• Device Lot Number: 15DR01007
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 117