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 Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Death (1802)

Event Date 01/28/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The post market surveillance department has requested medical records and treatment sheets for this reported event but none have been provided to date.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 progress.A supplemental medwatch will be submitted.

Event Description

An inpatient user facility reported during treatment a patient expired due to a pulmonary embolism after being taken off of the machine due to the patient experiencing cardiac arrest during treatment.The user facility technician confirmed there was no alarm, no indication of a malfunction during treatment.The biomed completed a post-treatment diagnostic, where he inspected the ultrafiltration (uf) of the unit.During the post-treatment diagnostic assessment a stroke test was performed.The machine was programmed to take 24 strokes, but during testing the machine took 24.2 strokes.During a simulated treatment, on the same machine in which the patient cardiac arrest occurred, 1050ml was pulled while the machine was programmed for 1000ml.

Manufacturer Narrative

Manufacturing evaluation: the device was not returned to the manufacturer for physical evaluation, and neither the lot # or catalog # were 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 bloodlines shipped to this account within the selected time frame.An investigation of the device manufacturing records was conducted by the manufacturer for all identified lots.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.Each identified lot passed all release criteria.Clinical assessment (provided by treating physician): on admission to user facility, the patient was found to have staph epi bacteremia and was treated and repeat cultures were negative at end of treatment.She had become increasingly resistant to hemodialysis, was combative with staff, and pulled her needles out on two treatments prior to day of death.On the day she expired, she was receiving a one on one session with a dialysis nurse and had an additional lpn (non-dialysis staff) to aid if patient became combative.She was on telemetry.She developed bradycardic arrest after approximately 45 minutes of dialysis that she had been tolerating well.She had been essentially bed bound for 8 weeks as she was not getting up and walking or getting physical therapy during hospitalizations.She refused to wear her scd¿s and refused many medications.Patient expiration believed to be most likely etiology of cardiac arrest.

• Brand Name: FMC BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa 88780 ; MX 88780
• Manufacturer (Section G): REYNOSA PLANT; erika de reynosa,s.a. de c.v.; mike allen 1331 parque; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5460906
• MDR Text Key: 39040731
• Report Number: 8030665-2016-00090
• 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: user facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR