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 Hypervolemia (2664)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review could not be performed as a serial number was not provided.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached.Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008 machine, and the serious adverse event of fluid retention, which warranted hospitalization.The etiology of the fluid overload is unknown; therefore, causality cannot firmly be established.Given the anonymous reporting of the serious adverse event, an inability to obtain additional information precluded a more comprehensive investigation.Fluid retention is a well-known complication of the esrd disease process and is frequently caused by multiple factors.Based on the information available, the 2008 machine 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 event(s).Furthermore, it is unknown if the patient was utilizing a fresenius product(s) and/or device(s) when the serious adverse events occurred.

Event Description

It was reported to fresenius (via a customer experience survey) this anonymous patient with end stage renal disease (esrd) hemodialysis (hd) for renal replacement therapy (rrt) was hospitalized due to fluid retention.It was noted by the patient in their survey response that they also had heart damage.Knowledge of the hospitalization for fluid retention was obtained from a customer experience survey in which the patient chose to remain anonymous.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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15520953
• MDR Text Key: 300994538
• Report Number: 0002937457-2022-01638
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/02/2021
• 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