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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190713
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Exsanguination (1841); Blood Loss (2597)
Event Date 08/26/2017
Event Type  Death  
Manufacturer Narrative
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
 
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. The catheter and the bloodlines were reportedly still connected but only barely. The access site was reported to have been uncovered. 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) 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. The clinic manager reported that there is no suspected cause for the bloodlines to have disconnected from the catheter. It was reported that the nurse verified tight connection prior to the start of the patient¿s treatment. No 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 reported complaint was not confirmed and a definitive conclusion regarding the complaint incident cannot be reached as the device was not returned to the manufacturer for physical evaluation. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances or any rework during the manufacturing process which could be associated with the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The investigation into the cause of the reported problem was not able to be confirmed. 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.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key6945062
MDR Text Key89172457
Report Number2937457-2017-01021
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
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 Received10/12/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number190713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received10/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/12/2017 Patient Sequence Number: 1
Treatment
CATHETER, TUNNELED RIGHT JUGULAR; FRESENIUS BLOODLINES; FRESENIUS GRANUFLO (G3251); FRESENIUS HEMACLIP BLOODLINE CONNECTOR CLIP; FRESENIUS OPTIFLUX 160NRE DIALYZER; HEPARIN; MIRCERA; VANCOMYCIN HCL
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