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.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12479008
• MDR Text Key: 271647259
• Report Number: 2937457-2021-01907
• Device Sequence Number: 1
• Product Code: KDI
• 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,user faci
• Reporter Occupation: Biomedical Engineer
• 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

• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2010
• 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: 09/16/2021 Patient Sequence Number: 1