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

Catalog Number UNKNOWN- 2008 MACHINE

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

Patient Problems Dyspnea (1816); Pneumonia (2011); Electrolyte Imbalance (2196); Hypervolemia (2664)

Event Date 07/08/2022

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between hd therapy utilizing an unknown hemodialysis system, and the patient¿s serious adverse events of covid-19 pneumonia, hyperkalemia, and fluid overload, which warranted hospitalization.The definitive etiology of the events is unknown; therefore, causality cannot be established.However, the patient¿s pdrn reported the events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s).Fluid overload is a well-known potential complication of the esrd process.Causality can often be attributed to several different internal and external factors such as, physiological changes, mechanical issues, membrane/transport failure, non-compliance.Additionally, hyperkalemia is a common finding with regard to electrolyte imbalances in esrd patients, as the patients¿ lack of urinary output predisposes them to imbalances.Based on the information available, the patient¿s unknown hemodialysis system can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating the hemodialysis system caused or contributed to the serious adverse events.Furthermore, there is no report the device failed to meet manufacturer specifications.

Event Description

On (b)(6) 2022, fresenius became aware this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) was hospitalized.No additional information was provided during intake.The discharge summary was received on (b)(6) 2022, which revealed the patient presented to the emergency room (er) on (b)(6) 2022 for shortness of breath (dyspnea).The patient was reportedly undergoing outpatient hemodialysis (hd), and after approximately one hour into treatment the patient stated he became more dyspneic.Although the treatment data is unavailable, the patient reportedly left the clinic and went to the er.The patient¿s laboratory data indicated the patient was mildly hyperkalemic (5.2 mmol/l), and radiological studies indicated the patient was fluid overloaded.The patient was assessed by nephrology and ordered additional hd to remove the patient¿s excess fluid.Prior to treatment, the patient was experiencing periods of desaturation (mid 80¿s), however this was resolved (as well as the patient¿s dyspnea) following the removal of 4 liters of fluid during hd therapy.The patient was discharged home (with supplemental oxygen) on (b)(6) 2022 and has recovered from the serious adverse events.The patient¿s pd registered nurse (pdrn) confirmed the events were unrelated to the patient¿s utilization of a fresenius product(s) and/or device(s).

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number 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.

Event Description

On 26/jul/2022, fresenius became aware this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) was hospitalized.No additional information was provided during intake.The discharge summary was received on (b)(6)2022, which revealed the patient presented to the emergency room (er) on (b)(6) 2022 for shortness of breath (dyspnea).The patient was reportedly undergoing outpatient hemodialysis (hd), and after approximately one hour into treatment the patient stated he became more dyspneic.Although the treatment data is unavailable, the patient reportedly left the clinic and went to the er.The patient¿s laboratory data indicated the patient was mildly hyperkalemic (5.2 mmol/l), and radiological studies indicated the patient was fluid overloaded.The patient was assessed by nephrology and ordered additional hd to remove the patient¿s excess fluid.Prior to treatment, the patient was experiencing periods of desaturation (mid 80¿s), however this was resolved (as well as the patient¿s dyspnea) following the removal of 4 liters of fluid during hd therapy.The patient was discharged home (with supplemental oxygen) on (b)(6) 2022 and has recovered from the serious adverse events.The patient¿s pd registered nurse (pdrn) confirmed the events were unrelated to the patient¿s utilization of a fresenius product(s) and/or device(s).

Event Description

On 26/jul/2022, fresenius became aware this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) was hospitalized.No additional information was provided during intake.The discharge summary was received on 28/jul/2022, which revealed the patient presented to the emergency room (er) on (b)(6) 2022 for shortness of breath (dyspnea).The patient was reportedly undergoing outpatient hemodialysis (hd), and after approximately one hour into treatment the patient stated he became more dyspneic.Although the treatment data is unavailable, the patient reportedly left the clinic and went to the er.The patient¿s laboratory data indicated the patient was mildly hyperkalemic (5.2 mmol/l), and radiological studies indicated the patient was fluid overloaded.The patient was assessed by nephrology and ordered additional hd to remove the patient¿s excess fluid.Prior to treatment, the patient was experiencing periods of desaturation (mid 80¿s), however this was resolved (as well as the patient¿s dyspnea) following the removal of 4 liters of fluid during hd therapy.The patient was discharged home (with supplemental oxygen) on (b)(6) 2022 and has recovered from the serious adverse events.The patient¿s pd registered nurse (pdrn) confirmed the events were unrelated to the patient¿s utilization of a fresenius product(s) and/or device(s).

• Brand Name: UNKNOWN-2008
• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15176393
• MDR Text Key: 297349938
• Report Number: 0002937457-2022-01306
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- 2008 MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male