MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190766

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

Patient Problem Loss of consciousness (2418)

Event Date 09/01/2021

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system, and the adverse events of loss of consciousness and death, which required the emergent discontinuation of hd therapy and initiation of emergency lifesaving measures.The definitive cause of the patients adverse events is unknown; therefore, causality cannot firmly be established.However, per the bmt, the serious adverse events occurred during hd therapy and the 2008t hemodialysis systems uf pump required recalibration.The esrd population continues to have significantly higher mortality (up to 30-fold higher), and fewer expected years of life when compared to the general population.Based on the limited information available, the 2008t hemodialysis system cannot be excluded from having a possible causal and/or contributory role in the patients serious adverse events and subsequent death.At this time there is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused and/or contributed to the events.However, given the patient was actively undergoing hd therapy when the events began, and the uf pump required recalibration during post-event testing; this clinical investigation cannot disassociate the device from the serious adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.¿.

Event Description

Fresenius became aware this patient with renal failure (rf) on hemodialysis (hd) for renal replacement therapy (rrt) lost consciousness during hd therapy.It was reported cardiopulmonary resuscitative (cpr) measures were undertaken, however the patient expired.The patients initial reason for admission was a broken femur.No additional information provided during intake.Subsequent attempts to obtain additional clinical information (e.G., discharge summary, death certificate, autopsy report, esrd death notification, patient demographics, treatment records) have thus far proven unsuccessful.On (b)(6) 2021, a bio-medical technician (bmt) was contacted to perform functional compliance and ultrafiltration (uf) testing on the 2008t hemodialysis system.A review of the uf problem identification checklist revealed the 2008t hemodialysis system required recalibration of the uf pump.During post-event testing, a uf pump error occurred, and the uf strokes were above the allowable limit at 1.008 ml/stroke (allowable limits = 0.996  1.004 ml/stroke) and was successfully recalibrated (elevated uf pump strokes would mean the 2008t hemodialysis system could potentially remove more fluid then what was programmed into the device).The remainder of the validation testing fell within manufacturer specifications.

Event Description

Fresenius became aware this patient with renal failure (rf) on hemodialysis (hd) for renal replacement therapy (rrt) lost consciousness during hd therapy.It was reported cardiopulmonary resuscitative (cpr) measures were undertaken, however the patient expired.The patient¿s initial reason for admission was a broken femur.No additional information provided during intake.Subsequent attempts to obtain additional clinical information (e.G., discharge summary, death certificate, autopsy report, esrd death notification, patient demographics, treatment records) have thus far proven unsuccessful.On 24/sep/2021, a bio-medical technician (bmt) was contacted to perform functional compliance and ultrafiltration (uf) testing on the 2008t hemodialysis system.A review of the ¿uf problem identification checklist¿ revealed the 2008t hemodialysis system required recalibration of the uf pump.During post-event testing, a uf pump error occurred, and the uf strokes were above the allowable limit at 1.008 ml/stroke (allowable limits = 0.996 ¿ 1.004 ml/stroke) and was successfully recalibrated (elevated uf pump strokes would mean the 2008t hemodialysis system could potentially remove more fluid then what was programmed into the device).The remainder of the validation testing fell within manufacturer specifications.

Manufacturer Narrative

Correction: d9 plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).The fst reviewed the ¿ultrafiltration (uf) problem identification checklist¿ which revealed the 2008t machine required calibration of the uf pump as the uf pump error occurred and the uf strokes were measured at 1.008 ml/stroke which is outside the allow limits of 0.996 -1.004 ml/stroke.To resolve the reported issue, the fst successfully re-calibrated the uf pump.The remainder of the functional testing fell within manufacturer specification.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 of the machine by the fst was able to confirm the reported failure mode.Therefore, the complaint event was confirmed.

Event Description

On 09/23/2021 a biomedical technician (bmt) contacted fresenius technical service to request an ultrafiltration (uf) problem identification checklist be performed on a 2008t fresenius hemodialysis (hd) machine.A fresenius field service technician (fst) performed the checklist which revealed the 2008t hemodialysis system an error with the uf pump.During post-event testing, a uf pump error occurred.The uf pump calibration was off and found volume to consistently reach 26, the uf strokes were above the allowable limit at 1.008 ml/stroke (allowable limits = 0.996 ¿ 1.004 ml/stroke), and the uf pump error was above the allowable limit at -80 ml (maximum allowable error = +/-10ml for a 1 hour simulated patient run).The uf pump was successfully recalibrated to resolve the issue.The remainder of the functional testing fell within manufacturer specifications; however, per the fst report there was indication of patient involvement and patient injury/illness.Additional follow-up was performed on 09/29/2021 and it was reported that a male patient (age unknown) with renal failure (rf) on hd for renal replacement therapy (rrt) lost consciousness during hd therapy on approximately (b)(6) 2021.Per the fresenius area technical operations manager (atom), cardiopulmonary resuscitative (cpr) measures were undertaken, however the patient expired.The patient¿s initial reason for admission was reported to be for a broken femur.Subsequent attempts to obtain additional clinical information (e.G., discharge summary, death certificate, autopsy report, esrd death notification, patient demographics, treatment records, and cause of death) were made, however to date additional information has not been provided.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12615846
• MDR Text Key: 275955139
• Report Number: 2937457-2021-02039
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• 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
• Patient Outcome(s): Required Intervention; Death
• Patient Sex: Male