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

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

Patient Problems Encephalopathy (1833); Pneumonia (2011); Sepsis (2067); Urinary Tract Infection (2120); Confusion/ Disorientation (2553)

Event Date 01/02/2024

Event Type  Death  

Event Description

On 27/mar/2024, fresenius became aware via a social media post (facebook) this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) was hospitalized for sepsis and fourteen ¿mini¿ strokes.The patient was reportedly hospitalized for all of on (b)(6) 2024.Follow-up documentation revealed the patient was hospitalized on (b)(6) 2024 with acute encephalopathy, altered mental status, severe sepsis secondary to a pseudomonas urinary tract infection (uti), and pseudomonas bacteremia.Following admission, the patient was also diagnosed with left lower lobe pneumonia (pna) and multiple focal supratentorial diffusion weight abnormalities (consistent with acute infarcts) secondary to tiny shower emboli noted via magnetic resonance imaging (mri) on (b)(6) 2024.Additionally, a small acute infarct involving the lateral aspect of the left cerebral hemisphere was also noted.The patient was obtunded upon arrival and was intubated for airway protection, and later extubated on (b)(6) 2024.The patient was initially treated with intravenous (iv) vancomycin, cefepime, and azithromycin (dosages, frequency, duration not provided), however the patient¿s health was further compromised due to worsening mental status (specifics not provided).The patient underwent an echoencephalograph (eeg) on (b)(6) 2024 which showed signs of metabolic encephalopathy.The patient¿s altered mental status was felt to be multifactorial in origin due to the multiple infarcts, sepsis secondary to pseudomonas uti, pseudomonas bacteremia, and left lower lobe pna.There was also concern for possible neurotoxicity secondary to the cefepime, which was discontinued and replaced with iv meropenem in an effort to rule out neurotoxicity.A feeding tube was placed for nutrition and medications, and on (b)(6) 2024, the patient was transferred to a long-term acute care hospital (ltac) for rehabilitation.The patient¿s mental status demonstrated mild improvement while hospitalized, however she remained largely nonverbal and could not follow commands.The patient was discharged home from the ltac on (b)(6) 2024 in stable condition.Of note: following discharge from the ltac, the patient lived with her daughter until on (b)(6) 2024, when she passed away.Per the patient¿s registered nurse, the patient was not undergoing hd when she expired, nor was it related to any fresenius device(s) and/or product(s).Therefore, a new complaint file will not be created.Per the patient¿s clinic manager (cm), the serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s).

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 an unknown 2008 hemodialysis system, and the serious adverse events of encephalopathy, altered mental status, severe sepsis, uti, bacteremia, pna, and multiple small infarcts (mini strokes), which required a prolonged hospitalization and antibiotic therapy.The discharge summary attributes causality of the serious adverse events (excluding the pna) to the untreated pseudomonas uti.Per the cm, the serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s).However, a temporal relationship does not exist between hd therapy utilizing an unknown 2008 hemodialysis system, and the serious adverse event of death, as the patient was not undergoing hd therapy when she expired.Septic shock is a life-threatening condition with a mortality rating of 12-22% and is primarily caused by severe bacterial infections.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 information available, the unknown 2008 hemodialysis system can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there was no report that a fresenius device(s) and/or product(s) failed to meet the users¿ expectations or manufacturers¿ specifications.

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.Complaint investigation did not find objective evidence indicating a product problem, thus the complaint is unconfirmed.

Event Description

On 27/mar/2024, fresenius became aware via a social media post (facebook) this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) was hospitalized for sepsis and fourteen ¿mini¿ strokes.The patient was reportedly hospitalized for all of (b)(6) 2024.Follow-up documentation revealed the patient was hospitalized on (b)(6) 2024 with acute encephalopathy, altered mental status, severe sepsis secondary to a pseudomonas urinary tract infection (uti), and pseudomonas bacteremia.Following admission, the patient was also diagnosed with left lower lobe pneumonia (pna) and multiple focal supratentorial diffusion weight abnormalities (consistent with acute infarcts) secondary to tiny shower emboli noted via magnetic resonance imaging (mri) on (b)(6) 2024.Additionally, a small acute infarct involving the lateral aspect of the left cerebral hemisphere was also noted.The patient was obtunded upon arrival and was intubated for airway protection, and later extubated on (b)(6) 2024.The patient was initially treated with intravenous (iv) vancomycin, cefepime, and azithromycin (dosages, frequency, duration not provided), however the patient¿s health was further compromised due to worsening mental status (specifics not provided).The patient underwent an echoencephalograph (eeg) on (b)(6) 2024 which showed signs of metabolic encephalopathy.The patient¿s altered mental status was felt to be multifactorial in origin due to the multiple infarcts, sepsis secondary to pseudomonas uti, pseudomonas bacteremia, and left lower lobe pna.There was also concern for possible neurotoxicity secondary to the cefepime, which was discontinued and replaced with iv meropenem in an effort to rule out neurotoxicity.A feeding tube was placed for nutrition and medications, and on (b)(6) 2024, the patient was transferred to a long-term acute care hospital (ltac) for rehabilitation.The patient¿s mental status demonstrated mild improvement while hospitalized, however she remained largely nonverbal and could not follow commands.The patient was discharged home from the ltac on (b)(6) 2024 in stable condition.Of note: following discharge from the ltac, the patient lived with her daughter until (b)(6) 2024, when she passed away.Per the patient¿s registered nurse, the patient was not undergoing hd when she expired, nor was it related to any fresenius device(s) and/or product(s).Therefore, a new complaint file will not be created.Per the patient¿s clinic manager (cm), the serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(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: 19094443
• MDR Text Key: 339980820
• Report Number: 0002937457-2024-00605
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• 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
• Report Date: 05/28/2024

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 05/28/2024
• Supplement Dates FDA Received: 05/28/2024
• 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
• Treatment: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Outcome(s): Death; Life Threatening; Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 68 KG