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

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

Patient Problem Sudden Cardiac Death (2510)

Event Date 02/23/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The end stage renal disease death notification (form (b)(6)) lists cause of death as cardiac arrest, cause unknown.The post market surveillance department is in the process of reviewing patient medical records related to this event.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.The post market surveillance department is in the process of reviewing patient medical records and treatment sheets.The plant investigation is in process.A supplemental mdr will be submitted at the completion of these activities.

Event Description

A user facility reported that a patient coded while undergoing a hemodialysis (hd) treatment on (b)(6) 2016.Prior to the hd treatment, the patient was usual self.The clinic manager provided follow-up information which revealed that the patient became unresponsive approximately 14 minutes into the treatment.A total of 2.8 liters normal saline was administered, but the patient did not respond.Cardiopulmonary resuscitation (cpr) and oral airway o2 via tank @ 100% were initiated.Additionally, an aed was placed; however, the unit indicated no shock.The patient was transported to the hospital with ems, but expired en route per verbal account from the er nurse.No device malfunctions reported prior to the patient becoming unresponsive.No issue with the 2008t hemodialysis machine observed.No samples of the acid/bicarb in use that day are available.The disposable products (dialyzer and bloodlines) are not available for evaluation by the manufacturer as both were discarded by the user facility.

Manufacturer Narrative

Additional information ¿ relevant tests/laboratory data, and other relevant history.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 bloodline tubing sets shipped to this account within the selected time frame.A records review was performed on each identified lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.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.Clinical investigation: the patient medical records were provided by the facility on march 19, 2016 and april 27, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.The end stage renal disease (esrd) patient receives in-center hemodialysis (hd) therapy carried out through fresenius products thrice weekly.The patient started on hemodialysis therapy on (b)(6) 2008.The medical records did contain the hd clinical notes report dated (b)(6) 2016 and the esrd death notification ((b)(4)) document.Medical records did not contain ambulance or hospital records, a death certificate, or autopsy report for review.There is no documentation in the medical record to indicate a causal relationship between the fresenius products used during the hd treatment, which included a 2008t hemodialysis (hd) machine, a dialyzer, 2k granuflo, and bicarb 4000 rx12, and the patient¿s death.

Event Description

The following additional event details were identified during a review of the patient's medical records.The patient presented to the clinic on (b)(6) 2016 for a routine hemodialysis (hd) treatment session.The patient was fully conscious and well oriented.Within 14 minutes of initiation of the hd treatment the patient became unresponsive and coded.The registered nurse (rn) placed the patient in a trendelenburg position, and administered a normal saline infusion.The patient failed to respond to these measures.At this time an oxygen mask with 15 liters was placed on the patient and cardiopulmonary resuscitation (cpr) was initiated at 10:30 am.At 10:33 am an oral airway was placed with placement of ambubag for mechanical respiration with 100% oxygen.An automated external defibrillator (aed) was applied, but no shock was advised.At 10:38 am emergency medical services (ems) arrived and continued resuscitation efforts.At 11:00 am the patient was transported to the hospital.The patient expired prior to reaching the hospital per verbal report from the emergency room rn.

• Brand Name: FMC BLOODLINES
• 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: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5516745
• MDR Text Key: 40889247
• Report Number: 8030665-2016-00139
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 ACID CONCENTRATE
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 72