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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190610
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 10/20/2017
Event Type  Death  
Manufacturer Narrative
Correction: updated the actual device was not returned to the manufacturer for physical evaluation. However, an investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.
 
Manufacturer Narrative
A supplemental mdr will be submitted upon device evaluation. The patient was initially assessed by their nephrologist for drain complications and abdominal pain which resulted in hospitalization on (b)(6) 2017; with the diagnosis of pd catheter failure. The surgical removal of the nonfunctioning pd catheter occurred on (b)(6) 2017 (not a fresenius device). At which point the patient was transition to hd therapy for dialysis. Although it appears the removal of the pd catheter did not alleviate the patients abdominal pain, nausea or vomiting. Additionally, the patient had an ng tube to suction during the hospital period as well as multiple radiographic studies. It appears that the patient had a cardiac event of pea and cardiac arrest approximately 2 hours after a hd treatment. Suggesting a possible temporal association between the hd treatment with the2008k2 machine and the adverse event(s) of pea, cardiac arrest and death, however, there is no documentation or evidence indicating a causal relationship between the 2008k2 hd machine, and the adverse event(s) of pea, cardiac arrest and subsequent death. Additionally, there was no reported adverse event during hd treatment on (b)(6) 2017 with the exception of abdominal pain which was an ongoing issue with this patient. There is no allegation against the 2008k machine or any allegation that the device did not perform as intended and the adverse event(s). Although medical records were received they did not include progress note, nurses¿ notes or record of resuscitation efforts. Additional information has been requested. The death notification dated (b)(6) 2017 lists the time of death at 13:57 from ¿consequences due to cardiac arrest. ¿.
 
Event Description
During follow up on an unrelated event it was reported that the patient had been hospitalized due to peritoneal dialysis catheter failure. The patient was transitioned to hemodialysis (hd). Patient was diagnosed with respiratory methicillin resistant staphylococcus auroras (mrsa) and was placed on airborne precautions; of note this was hospital acquired as the patient was negative for this upon admission through the emergency room. Records indicate the patient received hd on consecutive days (b)(6) 2017 through, (b)(6) 2017. The (b)(6) 2017 treatment data shows total ordered treatment time was 3. 5 hours utilizing left upper arm fistula. The ordered ultrafiltration (uf) was a net fluid removal of zero ml. This was accomplished by a total uf of 500 ml, to remove the 250 ml normal saline (ns) prime volume and 250 ml of ns given to discontinue to the treatment. Per the nursing note the patient tolerated the treatment well, resting with his eyes closed for most of the treatment, with no apparent signs of respiratory or other distress. Per the dialysis treatment record the 2008k2 machine passed all pre-treatment safety checks, conductivity validation, total dissolved solid testing and narrow venous limit testing. Additionally there is no documentation or evidence to suggest the machine did not performed within specification at time of treatment nor was there any reported machine alarms. The patient was returned to his room at approximately 10:50. On (b)(6) 2017 sometime between 12:06 and 13:20 the patient had an episode of pulseless electrical activity (pea) on the medical/surgical unit (exact time unknown). Cardiopulmonary resuscitation (cpr) was initiated with restoration of spontaneous circulation (rosc). However, during patient transfer to the intensive care unit (icu) the patient again went into pea. Advance cardiac life support measures were administered. A weak pulse and rosc were briefly obtained in the icu, however further resuscitative measures were unsuccessful in reviving the patient. The patient was pronounced dead at 13:57. The preliminary cause of the death as listed by the icu physician was cardiac arrest.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
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 Key7096812
MDR Text Key105939228
Report Number2937457-2017-01305
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190610
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 Received12/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2010
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: 12/07/2017 Patient Sequence Number: 1
Treatment
ACTIVATED CHARCOAL-SORBITOL; ASPIRIN; B COMPLEX WITH FOLIC ACID; BISACODYL; BLOOD LINE; CALCITRIOL; COLACE; DOXAZOSIN; GENTAMYCIN; HYDROCODONE-ACETAMINOPHEN; LACTULOSE; LEVOTHYROXINE; LORATADINE; LOSARTAN; NIFEDIPINE; OMEPRAZOLE; OPTIFLUX 160NR DIALYZER; SALINE; SIMETHICONE; SIMVASTATIN; VITAMIN C; VITAMIN D2
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