MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN-2008K MACHINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fungal Infection (2419)

Event Date 09/01/2002

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between hemodialysis utilizing the 2008k hemodialysis machine with saline priming bucket (spb) and the patient event of bloodstream infection with candida tropicalis.The thorough investigation of the c tropicalis outbreak among 3 dialysis units resulted in the probable cause as improper and infrequent disinfection of the spbs by the dialysis unit personnel.This is supported by the end of the outbreak as no additional cases of infection resulted once routine disinfection of the spbs were instituted.A potentially important finding was the retrieval of c tropicalis from both the hollow handle as well as the main compartment of several of the spbs.Even though several of the spbs had a glued plastic plate covering the top of the hollow handle, contaminated fluid was still able to leak into the handle.This fluid remained even after emptying the bucket.A subsequent investigation in 2018 recovered c tropicalis in the spb handle but not the main compartment which suggests difficulty in disinfecting buckets with hollow handles.This can increase the risk for infection.Therefore, there is a causal relationship between the improper disinfection of the spb on the 2008k hemodialysis machine and the bloodstream infection.Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported to fresenius on (b)(6) 2021 that an article was published in the american journal of infection control on (b)(6) , 2021 which references an infection outbreak related to the saline priming buckets (spb) on the 2008h and 2008k hemodialysis (hd) machines.The infection outbreak affected eight patients in three out of four dialysis clinics that were part of a hd network under a teaching hospital in new haven, ct during the period of (b)(6) 2002 and (b)(6) 2002.The clinics were designated as units a, b, c, and d.Unit a noted two infections where the patients had blood cultures resulting positive for candida tropicalis.Candida accounts for less than 1% of all bloodstream infections in hd patients per the national safety healthcare network.These blood culture results triggered unit a to notify the hospital infection control personnel.An extensive investigation was launched which included a computer search for all positive blood culture results for c tropicalis between (b)(6) 2002, and (b)(6) 2002 for all four dialysis units within the hospital network.Additionally, a daily review of microbiology lab reports was conducted.The investigation included observations and reviews of several areas.Clinical observations included interviews with staff regarding protocols for maintenance and disinfection of dialysis machines and spbs, administration of medication, and hand hygiene as well as many more.The microbiological investigation included environmental cultures from drains used for the reverse-osmosis (ro) water outlets, hoses, and tap water tubing.Spbs containing turbid fluid had samples taken as they were noted to not be routinely disinfected between uses.The acid and bicarbonate dialysis concentrates were also tested.In addition, personnel had their hands swabbed and cultured.The results of the extensive investigation identified eight patients in the period (b)(6) through (b)(6) 2002 to have cultured positive for c tropicalis.Those patients were dialyzed at units a, b, and c.Unit d did not have any positive cases.The patients were numbered according to date of diagnosis.This patient was dialyzing in unit cfor acute renal failure and was cultured positive for c tropicalis in early (b)(6).This patient utilized a femoral quinton (non-tunneled central line catheter) for dialysis access.C tropicalis was recovered in multiple sites which included 10 out of 30 spbs located in units a-d.Five of the 10 positive spbs were from machines used to dialyze 7 of the case patients at units a and b.At unit b, c tropicalis was recovered from hollow handles of spbs that contained turbid fluid.One of these had turbid fluid containing c tropicalis in both the main compartment and in the hollow handle even though there was the presence of a plastic ¿saline bucket plate¿ that had been attached to the top of the handle.There were other environmental cultures that resulted positive for c tropicalis including ro product water, drains in wall boxes, and ro reject water which was located in the micu at unit c.No deficiencies in skin preparation, use of multidose vials of medications, or dialysis machine disinfection were noted.Dialysis supplies and medications used at units a-d were from the same suppliers.No deficiencies of the water distribution were identified.The most likely source of the outbreak was identified as the spb.This is based on the failure to routinely disinfect spbs and allowing dialysis tubing to come in contact with contaminated fluid in spbs as well as the recovery of c tropicalis isolates with indistinguishable patterns from case patients and contaminated spbs of machines used to dialyze several case patients.Lastly the results of no additional positive cases and the end of the outbreak following routine disinfection of spbs.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation and no on-site evaluation was performed by a fresenius field service technician (fst).Additionally, the serial number of the machine could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported to fresenius on june 15, 2021 that an article was published in the american journal of infection control on february 22, 2021 which references an infection outbreak related to the saline priming buckets (spb) on the 2008h and 2008k hemodialysis (hd) machines.The infection outbreak affected eight patients in three out of four dialysis clinics that were part of a hd network under a teaching hospital in (b)(6) during the period of (b)(6) 2002.The clinics were designated as units a, b, c, and d.Unit a noted two infections where the patients had blood cultures resulting positive for candida tropicalis.Candida accounts for less than 1% of all bloodstream infections in hd patients per the national safety healthcare network.These blood culture results triggered unit a to notify the hospital infection control personnel.An extensive investigation was launched which included a computer search for all positive blood culture results for c tropicalis between (b)(6) 2002 for all four dialysis units within the hospital network.Additionally, a daily review of microbiology lab reports was conducted.The investigation included observations and reviews of several areas.Clinical observations included interviews with staff regarding protocols for maintenance and disinfection of dialysis machines and spbs, administration of medication, and hand hygiene as well as many more.The microbiological investigation included environmental cultures from drains used for the reverse-osmosis (ro) water outlets, hoses, and tap water tubing.Spbs containing turbid fluid had samples taken as they were noted to not be routinely disinfected between uses.The acid and bicarbonate dialysis concentrates were also tested.In addition, personnel had their hands swabbed and cultured.The results of the extensive investigation identified eight patients in the period (b)(6) 2002 to have cultured positive for c tropicalis.Those patients were dialyzed at units a, b, and c.Unit d did not have any positive cases.The patients were numbered according to date of diagnosis.This patient was dialyzing in unit cfor acute renal failure and was cultured positive for c tropicalis in early (b)(6) 2002.This patient utilized a femoral quinton (non-tunneled central line catheter) for dialysis access.C tropicalis was recovered in multiple sites which included 10 out of 30 spbs located in units a-d.Five of the 10 positive spbs were from machines used to dialyze 7 of the case patients at units a and b.At unit b, c tropicalis was recovered from hollow handles of spbs that contained turbid fluid.One of these had turbid fluid containing c tropicalis in both the main compartment and in the hollow handle even though there was the presence of a plastic ¿saline bucket plate¿ that had been attached to the top of the handle.There were other environmental cultures that resulted positive for c tropicalis including ro product water, drains in wall boxes, and ro reject water which was located in the micu at unit c.No deficiencies in skin preparation, use of multidose vials of medications, or dialysis machine disinfection were noted.Dialysis supplies and medications used at units a-d were from the same suppliers.No deficiencies of the water distribution were identified.The most likely source of the outbreak was identified as the spb.This is based on the failure to routinely disinfect spbs and allowing dialysis tubing to come in contact with contaminated fluid in spbs as well as the recovery of c tropicalis isolates with indistinguishable patterns from case patients and contaminated spbs of machines used to dialyze several case patients.Lastly the results of no additional positive cases and the end of the outbreak following routine disinfection of spbs.The doctor did not provide information during followup regarding antibiotic treatment but confirmed the patient recovered.

• Brand Name: 2008K MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 12155181
• MDR Text Key: 264982429
• Report Number: 2937457-2021-01454
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN-2008K MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR