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

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

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.

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.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• Type of Device: DIALYZER, 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 Key: 7096812
• MDR Text Key: 94147034
• Report Number: 2937457-2017-01305
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• 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 Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• 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
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 114