MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems Cardiac Arrest (1762); Death (1802); Exsanguination (1841); Blood Loss (2597)

Event Date 08/26/2017

Event Type  Death  

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.Therefore, the reported complaint could not 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 patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodline products shipped to this account within the selected time frame.A records review was performed on a total of 15 lots identified.There are no samples available as the entire lots have been distributed.An investigation of the device history records (dhr) was conducted by the manufacturer.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.

Event Description

A hemodialysis (hd) patient arrived to the facility on (b)(6) 2017 for a regularly scheduled four-hour hd treatment via right tunneled jugular catheter.The hd treatment was initiated at 7:05am with no patient complaints.At 9:00am, the patient¿s blood pressure (bp) was 95/50 and pulse was 69 beats per minute.At approximately 9:15am, a nurse found the patient unresponsive with blood leaking between the arterial connector of the patient¿s arterial tunneled jugular catheter and the arterial portion of the fresenius bloodlines.Cardiopulmonary resuscitation (cpr) was initiated, emergency medical services (ems-911) was called, and the patient was given 2000 cubic centimeters (cc) of normal saline (ns).The patient was transported via ambulance to (b)(6) hospital emergency room by paramedics.Per the ems report, the patient was found at the dialysis facility in full cardiac arrest and had lost approximately 1.5 to 2.0 liters of blood from the dialysis catheter.Ems had given the patient epinephrine four times in the ambulance.Ems arrived at the hospital emergency department at 9:48am and was given additional care but was subsequently pronounced dead at 10:05am.The patient¿s cause of death was reported as unknown, with secondary causes of cardiac arrest (cause unknown) and hemorrhage from vascular access.It was reported that the 2008t hd machine in use at the time of the treatment did not alarm or provide any errors at the time of the incident.The 2008t hd machine was removed from service following the event for an evaluation by the facility¿s on-site biomedical technician (biomed).The biomed verified machine operations and returned the machine to service at the user facility.No of fresenius products or devices that were in use during the hd treatment are available to be returned to the manufacturer for analysis.

Manufacturer Narrative

Plant investigation: the manufacturer completed a verification and review of the product instructions for use (ifu) which is included in the product packaging (p/n 71-4210).The ifu provides directions on bloodline correct connection steps and warnings.Clinical investigation: a temporal association exists with the adverse events of the patient¿s blood loss, cardiac arrest, and eventual death, and the fresenius 2008t hemodialysis (hd) machine and bloodlines.However, there is no documentation of any defects at the connection site of the arterial bloodline to the catheter or any other arterial bloodline issues leading up to the event that would cause the loose connection.It is unknown what may have occurred to cause the catheter and arterial bloodline to become unsecure two hours after the initiation of hd therapy.It is also unclear why the reported blood leak was not observed prior to the patient losing consciousness as it was reported that the catheter site was uncovered.Additionally, it was reported that the machine did not alarm and the blood pressure parameters were not exceeded.It is not known if the pressure in the arterial line had changed.The adverse event was a direct results of the patient¿s dialysis arterial line becoming unsecure and partially detaching from the catheter connection leading to the blood loss, cardiac arrest, and death.Additional information: patient codes method codes.

• Brand Name: FMC BLOODLINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6944474
• MDR Text Key: 89142066
• Report Number: 8030665-2017-00830
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/18/2017
• 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: CATHETER, TUNNELED RIGHT JUGULAR; FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE; FRESENIUS GRANUFLO (G3251); FRESENIUS HEMACLIP BLOODLINE CONNECTOR CLIP; FRESENIUS OPTIFLUX 160NRE DIALYZER; HEPARIN; MIRCERA; VANCOMYCIN HCL
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 83