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 Cardiac Arrest (1762)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system, and the adverse event of cardiac arrest.The definitive cause of the patient¿s adverse event(s) is unknown; therefore, causality cannot firmly be established.Given the patient¿s identity remains unknown, an inability to obtain additional information precluded a more comprehensive investigation.Based on the totality of the information available, the 2008 hemodialysis system cannot be excluded from having a possible causal and/or contributory role in the serious adverse events.At this time, there is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction occurred.However, given the patient was reportedly undergoing hd therapy when the events began and the lack of additional information (e.G., treatment record, hospital records, timeline, patient demographics); his clinical investigation cannot disassociate the device from the serious adverse events.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.Should additional relevant information become available, a supplemental report will be submitted. .

Event Description

Fresenius became aware (via a customer experience survey) that this unknown patient with end stage renal disease (esrd) previously on hemodialysis (hd) for renal replacement therapy (rrt) ¿coded¿ (cardiac arrest) during treatment.No additional information was provided during intake.Knowledge of the cardiac arrest was obtained from a customer experience survey in which the patient was not named.As such, written or telephonic follow-up was not possible.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13957341
• MDR Text Key: 288371815
• Report Number: 2937457-2022-00518
• 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
• Report Date: 03/30/2022

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: 04/02/2021
• Initial Date FDA Received: 03/30/2022
• 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): Required Intervention