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 Problem Anemia (1706)

Event Date 08/01/2023

Event Type  Death  

Manufacturer Narrative

Clinical review: it is unknown if a temporal relationship exists between hd therapy utilizing the unknown 2008 hemodialysis system and the serious adverse events of anemia and death, as it is unknown when the events occurred.The patient¿s cause of death remains unknown; therefore, causality could not be firmly established.It should be noted that an inability to obtain additional clinical information precluded a more in-depth investigation.The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population additionally, adults with esrd have mortality rates up to 30-fold higher than the general population.Based on the information available, the patient¿s 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 a fresenius device(s) and/or product(s) failed to meet the users¿ expectations or manufacturers¿ specifications.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

Fresenius became aware via a social media post (facebook) that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) expired (date not provided).The facebook posting indicated the patient¿s hemoglobin (anemia) and oxygen levels were dropping despite being given iron injections during the past 2 hd treatments.Although the timeline of events is unknown, the patient complained to the reporter that they were feeling unwell and subsequently passed away (specifics unknown).A lack of contact information prevented this reviewer from obtaining any additional information [e.G., discharge summary (if applicable), esrd death notification, autopsy report, treatment data (if applicable), death certificate].

Event Description

Fresenius became aware via a social media post (facebook) that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) expired (date not provided).The facebook posting indicated the patient¿s hemoglobin (anemia) and oxygen levels were dropping despite being given iron injections during the past 2 hd treatments.Although the timeline of events is unknown, the patient complained to the reporter that they were feeling unwell and subsequently passed away (specifics unknown).A lack of contact information prevented this reviewer from obtaining any additional information [e.G., discharge summary (if applicable), esrd death notification, autopsy report, treatment data (if applicable), death certificate].

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.

• 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: 17691389
• MDR Text Key: 322745829
• Report Number: 0002937457-2023-01356
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- 2008 MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/20/2023
• 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): Death
• Patient Sex: Male