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

Model Number 190610

Device Problem Pumping Problem (3016)

Patient Problem Loss of consciousness (2418)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008k2 hemodialysis system and the serious adverse event(s) of loss of consciousness (loc), which warranted evaluation/observation in the er following completion of treatment.The cause of the patient¿s loc was never clinically identified, however the outpatient dialysis clinic¿s bmt attributed the event(s) to a 2008k2 hemodialysis system bicarbonate pump failure (¿not pulling¿).Limited information precluded a more in-depth investigation into the clinical events.While advances in technology have significantly reduced the number of serious adverse events incurred during hd therapy, the 2008k2 hemodialysis system cannot be excluded from having a possible causal or contributory role in the serious adverse event(s).There is no tangible or objective evidence indicating the 2008k2 hemodialysis system malfunctioned on (b)(6) 2021, as the bicarbonate pump was discarded after replacement.However, given the lack of definitive causality, treatment data, patient demographics, discharge summary and machine records, the 2008k2 hemodialysis system cannot be disassociated from the event(s).Furthermore, without the patient¿s medical history, it is unknown if any extraneous factors could have affected the patient¿s hemodynamic stability during hd therapy.

Event Description

It was reported to fresenius that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) lost consciousness during hd therapy on (b)(6) 2021.Follow-up with the facility clinic manager (cm) confirmed the patient lost consciousness approximately 10 minutes into hd therapy on (b)(6) 2021.The patient was given a normal saline bolus (volume unknown) and while preparing to initiate cardiopulmonary resuscitation measures, the patient regained consciousness.The patient continued treatment utilizing the same 2008k2 hemodialysis system without further issue.Following treatment, the patient was sent to the emergency room (er) via medical transport and kept overnight for observation (<24 hours).Per the cm, no medical intervention was provided at the hospital.Additional information was requested (e.G., machine records, treatment record, patient demographics, discharge summary), however the request was declined.The 2008k2 hemodialysis system was not sequestered following the event(s), and no rationale was provided.However, the cm stated no additional issues occurred with the machine until (b)(6) 2021 when the bicarbonate pump failed during therapy.No treatment data, machine records and/or functional compliance testing was supplied for (b)(6) 2021.The bicarbonate pump was later replaced on (b)(6) 2021, and is unavailable for manufacturer evaluation, as it was discarded.Limited information prevents the completion of a detailed and thorough investigation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, an on-site evaluation was not performed by a fresenius field service technician (fst).It was indicated that the bicarbonate pump failed and was replaced to resolve the reported issue.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 confirm the reported failure mode.Therefore, the complaint event was confirmed.

Event Description

It was reported to fresenius that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) lost consciousness during hd therapy on (b)(6) 2021.Follow-up with the facility clinic manager (cm) confirmed the patient lost consciousness approximately 10 minutes into hd therapy on (b)(6) 2021.The patient was given a normal saline bolus (volume unknown) and while preparing to initiate cardiopulmonary resuscitation measures, the patient regained consciousness.The patient continued treatment utilizing the same 2008k2 hemodialysis system without further issue.Following treatment, the patient was sent to the emergency room (er) via medical transport and kept overnight for observation (<24 hours).Per the cm, no medical intervention was provided at the hospital.Additional information was requested (e.G., machine records, treatment record, patient demographics, discharge summary), however the request was declined.The 2008k2 hemodialysis system was not sequestered following the event(s), and no rationale was provided.However, the cm stated no additional issues occurred with the machine until (b)(6) 2021 when the bicarbonate pump failed during therapy.No treatment data, machine records and/or functional compliance testing was supplied for (b)(6) 2021.The bicarbonate pump was later replaced on (b)(6) 2021, and is unavailable for manufacturer evaluation, as it was discarded.Limited information prevents the completion of a detailed and thorough investigation.

Event Description

It was reported to fresenius that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) lost consciousness during hd therapy on (b)(6) 2021.Follow-up with the facility clinic manager (cm) confirmed the patient lost consciousness approximately 10 minutes into hd therapy on (b)(6) 2021.The patient was given a normal saline bolus (volume unknown) and while preparing to initiate cardiopulmonary resuscitation measures, the patient regained consciousness.The patient continued treatment utilizing the same 2008k2 hemodialysis system without further issue.Following treatment, the patient was sent to the emergency room (er) via medical transport and kept overnight for observation (<24 hours).Per the cm, no medical intervention was provided at the hospital.Additional information was requested (e.G., machine records, treatment record, patient demographics, discharge summary), however the request was declined.The 2008k2 hemodialysis system was not sequestered following the event(s), and no rationale was provided.However, the cm stated no additional issues occurred with the machine until (b)(6) 2021 when the bicarbonate pump failed during therapy.No treatment data, machine records and/or functional compliance testing was supplied for (b)(6) 2021.The bicarbonate pump was later replaced on (b)(6) 2021, and is unavailable for manufacturer evaluation, as it was discarded.Limited information prevents the completion of a detailed and thorough investigation.

Manufacturer Narrative

Correction: b2, h10 (the final sentence of the plant investigation has been updated to state that a conclusion about the event could not be reached.) plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, an on-site evaluation was not performed by a fresenius field service technician (fst).It was indicated that the bicarbonate pump failed and was replaced to resolve the reported issue.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 confirm the reported failure mode.A definitive conclusion regarding the complaint incident cannot be reached.

• 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; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 12479008
• MDR Text Key: 271647259
• Report Number: 2937457-2021-01907
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention