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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
Catalog Number 190766
Device Problems Disconnection (1171); No Fail-Safe Mechanism (2990); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Dyspnea (1816); Exsanguination (1841); Confusion/ Disorientation (2553); Blood Loss (2597)
Event Date 10/27/2018
Event Type  Death  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
A user facility clinical manager (cm) reported that a patient expired following hemodialysis (hd) treatment. Seventeen minutes after the initiation of the patient¿s hemodialysis (hd) treatment, it was discovered that the prescribed blood flow rate (bfr) could not be achieved. The machine, a fresenius 2008t machine, did not alarm. Staff reversed the patient¿s bloodlines in an effort to improve the patient¿s bfr, and a hemaclip was applied to the arterial lumen and venous bloodline of the patient¿s hd catheter; the treatment was restarted. At approximately 15:30, the patient was observed having difficulty breathing and was visibly pale, and blood was noted on the patient¿s right finger. The patient¿s catheter ports were clamped and a saline bolus was administered. Although it is unknown if the hemaclip was attached to the catheter or the bloodline, it was confirmed that the hemaclip did not pose any imposition while the saline bolus was administered to the patient. It was noted that the venous bloodline separated from the arterial lumen of the patient¿s permanent hd catheter (not a fresenius product). It was confirmed that emergency medical services (ems) were called and cardiopulmonary resuscitative (cpr) was initiated. The patient expired in the emergency room at approximately 16:16. Additional information regarding the patient and the event was requested; however, not provided by the facility. The hospital declined to provide the patient¿s records to the clinic. Upon follow up, it was confirmed that the clinic did not contact the catheter manufacturer to confirm that the hemaclip was compatible with the patient¿s catheter type. It was also confirmed that the patient¿s catheter dressing was changed and that chloroprep was used at the catheter site. It was reported that the devices involved were discarded and there are no parts available for manufacturer evaluation.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res). 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 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 investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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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
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 Key8190454
MDR Text Key131186354
Report Number2937457-2018-03724
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/07/2018,01/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190766
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/07/2018
Distributor Facility Aware Date10/27/2018
Device Age1 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer11/08/2018
Date Manufacturer Received01/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/21/2018 Patient Sequence Number: 1
Treatment
FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS GRANUFLO DIALYSIS CONCENTRATE; FRESENIUS HEMACLIP; FRESENIUS NATURALYTE DIALYSIS CONCENTRATE
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