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 Death (1802)

Event Date 02/16/2016

Event Type  Death  

Manufacturer Narrative

(b)(4) the post market surveillance department is in the process of reviewing patient medical records and treatment sheets.A supplemental mdr will be submitted at the completion of this activity.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 plant investigation is in process.A supplemental mdr will be submitted at the completion of this activity.

Event Description

A user facility reported that a patient expired while at the clinic for their hemodialysis treatment.Reportedly, the patient had requested a pause in the treatment to use the restroom and collapsed while returning to the chair.The clinic manager (cm) provided follow-up information related to this event.The patient was in what was considered to be a normal state of health prior to beginning the treatment.Pretreatment vitals were taken and determined to be the following: blood pressure (bp) was 129/67; pulse (p) of 77 regular; respiratory rate of 17; temperature of 96.8; (b)(6).Approximately 2 hours 15 minutes into treatment, the patient complained of stomach cramping.At this time the patient's bp was 170/93 and p was 67.A normal 150ml saline bolus was administered for the cramping.Approximately 5 minutes later, the patient requested the treatment be paused.The patient's blood was returned at 13:45, and then the patient ambulated to the restroom.Approximately 10 minutes, while returning to the chair, the patient became anxious and weak, and was placed in a wheelchair.At 13:59, the patient was found to be unresponsive in the wheelchair and without a pulse.An automated external defibrillator was applied which advised to begin cardiopulmonary resuscitation (cpr).Emergency medical services (ems) was requested.Cpr continued for approximately 7 minutes until ems arrived, however, the patient expired.Following the event, the hemodialysis machine was removed from service for evaluation.The unit remains at the user facility.No parts are available for return to the manufacturer for analysis.

Manufacturer Narrative

Manufacturing investigation: the device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.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 blood lines shipped to this account within the selected time frame.A records review was performed on the 14 lots identified.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.The lots passed all release criteria.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 february 19, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.Medical records reveal that the patient was not on hemodialysis at the time she became pulseless and non-responsive.The patient had returned from the bathroom after being taken off dialysis.Prior to the non-responsive/pulseless episode, the patient was having dry heaves and stomach cramping.The patient had a history of coronary artery disease and congestive heart failure.Medical records do not contain a death certificate or autopsy report for review.The medical records do not contain ambulance or hospital progress notes from (b)(6) 2016.Medical records do not contain medication records, labs (including a recent bicarbonate or potassium level) or diagnostic tests for review.There were no symptoms prior to the administration of hemodialysis that indicated the patient was having any cardiopulmonary issues.In addition, the patient was receiving hemodialysis treatment and had been on hemodialysis for approximately the previous 22 months.Medical records do not contain any information that the patient had experienced any non-responsive or pulseless episodes during hemodialysis in the past.No malfunction was reported.The medical records do not contain any cause for the patient¿s pulseless episode.Medical records do not state there was any causal relationship between the fmc bloodlines and the pulseless episode and death.

• 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: 5508258
• MDR Text Key: 40602978
• Report Number: 8030665-2016-00125
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• 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: 04/15/2016
• 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 SALINE
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 41