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

Model Number	190610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional 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 cardiac arrest.The definitive cause of the patient¿s cardiac arrest is unknown; therefore, causality cannot be established.A lack of clinical information precluded a more in-depth investigation into the clinical event(s).However, during post event functional compliance and ultrafiltration testing, the 2008k2 hemodialysis system functioned as intended during the evaluation.Despite the complexity of performing hd therapy, life-threatening complications infrequently occur during treatment.Advances in technology (e.G., machine alarms, bacterial monitoring, preventative maintenance), have significantly reduced the number of serious adverse events incurred during hd therapy.Based on the information available, the 2008k2 hemodialysis system can be disassociated from the serious adverse event(s).There is no allegation or objective evidence indicating a fresenius product(s) and/or device(s) deficiency, defect or malfunction caused and/or contributed to the patient¿s serious adverse event(s).Furthermore, there was no report of any fresenius device(s) and/or product(s) failing to meet user expectations or manufacturer specifications.
Event or Problem Description
On 13/apr/2023, fresenius became aware (via a biomedical technician) this unknown patient with renal failure (rf) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a ¿code blue¿ (cardiac arrest) during hd therapy on (b)(6) 2023.No additional information was provided during intake.A review of the functional compliance testing and uf checklist performed on (b)(6) 2023 revealed the 2008k2 hemodialysis system performed within manufacturer specifications and was returned to service.Subsequent attempts to obtain additional clinical information (e.G., hd treatment data, timeline of events, causality, patient demographics, discharge summary, machine records, hospital records) were unsuccessful.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Field service technician investigation found objective evidence indicating a product problem, thus the complaint is confirmed.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 able to be confirmed.
Event or Problem Description
On 13/apr/2023, fresenius became aware (via a biomedical technician) this unknown patient with renal failure (rf) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a ¿code blue¿ (cardiac arrest) during hd therapy on (b)(6) 2023.No additional information was provided during intake.A review of the functional compliance testing and uf checklist performed on (b)(6) 2023 revealed the 2008k2 hemodialysis system performed within manufacturer specifications and was returned to service.Subsequent attempts to obtain additional clinical information (e.G., hd treatment data, timeline of events, causality, patient demographics, discharge summary, machine records, hospital records) were unsuccessful.
Event or Problem Description
On 13/apr/2023, fresenius became aware (via a biomedical technician) this unknown patient with renal failure (rf) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a ¿code blue¿ (cardiac arrest) during hd therapy on 12/apr/2023.No additional information was provided during intake.A review of the functional compliance testing and uf checklist performed on (b)(6) 2023 revealed the 2008k2 hemodialysis system performed within manufacturer specifications and was returned to service.Subsequent attempts to obtain additional clinical information (e.G., hd treatment data, timeline of events, causality, patient demographics, discharge summary, machine records, hospital records) were unsuccessful.
Additional Manufacturer Narrative
Correction: g3 date received for initial submission should have been 04/13/2023, h10 plant investigation: no parts were returned to the manufacturer for physical evaluation.Field service technician investigation found objective evidence indicating a product problem, thus the complaint is confirmed.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 symptom for uf pump alarm was confirmed.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• Common Device Name: 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16770983
• Report Number: 0002937457-2023-00580
• Device Sequence Number: 11548270
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K994267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2023

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?: Yes
• Operator of Device: Other
• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 06/19/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/22/2023; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown