MAUDE Adverse Event Report: CONCORD MANUFACTURING UNKNOWN-2008 MACHINE; 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 Insufficient Information (4580)

Event Date 04/17/2007

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: it is unknown if a temporal relationship exists between hd therapy utilizing the unknown 2008 hemodialysis system, and the serious adverse event of death.The definitive cause of the patient¿s expiration is unknown; therefore, causality cannot firmly be established.Given the limited follow-up information, a more comprehensive investigation could not be performed.Nevertheless, the end-stage renal disease (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 event(s).There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused or contributed to the serious adverse events.Furthermore, there is no evidence the patient was treated with a fresenius device and/or product.

Event Description

Fresenius became aware via a social media post that a hemodialysis (hd) patient expired during hd therapy on (b)(6) 2007.Multiple attempts were made to obtain additional information, and thus far, no further details have been provided.

Manufacturer Narrative

Plant investigation: no parts were 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.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

Fresenius became aware via a social media post that a hemodialysis (hd) patient expired during hd therapy on (b)(6) 2007.Multiple attempts were made to obtain additional information, and thus far, no further details have been provided.

• Brand Name: UNKNOWN-2008 MACHINE
• 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: 14281860
• MDR Text Key: 290680242
• Report Number: 0002937457-2022-00722
• 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: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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: 04/18/2022
• 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): Death
• Patient Sex: Female