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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190766
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144)
Event Date 04/04/2022
Event Type  Injury  
Manufacturer Narrative
Clinical investigation: there is a temporal relationship between hemodialysis (hd) treatment utilizing the 2008t machine and the patient event of cardiopulmonary arrest. However, there is no documentation to show a causal relationship. There is no allegation of a device malfunction or deficiency reported as causing or contributing to this event. Although a uf pump issue was noted during functional testing, the rn did not report any discrepancies in the patient¿s uf goal and end volume removed. The documentation provided by the clinic stated that the patient event was not related to a medical device or drug. The patient reported the cause of the event as a blockage requiring the placement of a cardiac stent. Hd patients experience high rates of cardiovascular morbidity and mortality with cardiac arrest rates exceeding the general population by 30-fold. The underlying risk factors of diabetes mellitus and peripheral vascular disease would also have increased the risk for cardiopulmonary arrest. Based on the available information and no allegation of a device malfunction or deficiency, the 2008t machine can be excluded as the cause of the patient¿s cardiopulmonary arrest. Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius field service technician (fst). 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-conformance's, or any associated rework identified during the manufacturing process which could be related to 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 cause of the reported issue cannot be confirmed and a definitive conclusion cannot be reached without a physical examination of the complaint device.
 
Event Description
It was reported to fresenius that this hemodialysis (hd) patient was in a regularly scheduled treatment when they coded with 1 hour and 33 minutes remaining in treatment. Treatment was discontinued and the patient was taken to the hospital. The patient was reportedly fine. During functional checks of the machine, it was noted that the ultrafiltration (uf) pump was pulling 24. 3ml in 24 strokes which is outside the ±0. 1 ml allowed. Additional information was obtained through follow-up with the hd clinic registered nurse (rn). This patient was at the clinic for a regularly scheduled four-hour hd treatment on the fresenius 2008t hemodialysis machine utilizing dialysate with 2. 0k and 2. 25ca content. The patient¿s pre-treatment vital signs were stable and within normal limits (no values provided). At 1400 hours, the patient care technician (pct) alerted the rn to the patient¿s blood pressure (bp) reading. The bp was 105/45 and heart rate (hr) 87. The rn evaluated the patient for hypotension. The patient was in the treatment chair and was alert and oriented to person, place, and time. The patient¿s bp was rechecked at 1403 and the reading was 86/39 hr 85. The patient was still alert and oriented to person, place, and time. The patient¿s uf goal was then reduced from 3. 8kg to 3kg. At this time, the rn administered 100ml of normal saline (ns). The patient stated they had a feeling of cramping and pressure in the breastbone region. The clinic documented chest tightness/pain and nausea/vomiting. The rn rechecked the bp which declined to 70/30 hr 87. The patient was in visual discomfort and was administered an additional 300ml ns. The rn called for assistance. The patient became pulseless and coded at 1407. Agonal breaths were noted. Sternum rubs were applied with no response by the rn and certified clinical hemodialysis technician (ccht). The charge nurse retrieved the crash cart. The patient was non-responsive with no vital signs. Chest compressions were initiated manually at 1407 and 200ml ns was administered for a total of 600ml administered. Emergency medical services (ems) was called at 1408 and a blood sugar check was 169. The ambu bag and automated external defibrillator (aed) were being prepared while a second set of compressions was administered at 1409. The patient had no pulse at this time and was nonresponsive. The patient took a breath and became responsive. Ems arrived at 1435. The medical director was contacted, as well as the facility administrator (fa), director of operations (do) and patient contact. The patient was transferred to ems care and transported to the hospital at 1440. At the time of transfer, the patient¿s bp was 137/53, and hr 89. The patient was alert and oriented and verbally responsive at the time. The patient was admitted to the hospital from ems transport from the clinic. The patient was discharged and returned to in-center hd on (b)(6) 2022 with no concerns. The patient reported the cause of the code was a blockage for which a stent will be required. The stent placement is pending. The rn reported that the patient¿s hospital records have been requested but not received. The patient reportedly did not experience any cardiac symptoms for the two weeks prior to the event or undergo any recent cardiac procedures or interventions. The reported information documented that no medical device or drug caused or contributed to the patient event. The patient¿s uf goal was set to be left above the estimated dry weight (not provided). The machine remains out of service pending return from the lab.
 
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Brand Name2008T HEMODIALYSIS SYSTEM W/BIBAG
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key14193802
MDR Text Key289980743
Report Number0002937457-2022-00677
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number190766
Device Catalogue Number190766
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received04/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2018
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: 04/25/2022 Patient Sequence Number: 1
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