MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008T

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Lethargy (2560)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

A temporal relationship exists between hd therapy on the 2008t hemodialysis machine and the adverse event(s) of hypotension and lethargy. However, there is no documentation or evidence indicating a causal relationship between the 2008t hemodialysis machine and the adverse event(s), as the machine performed within specification during follow-up functional compliance and ultrafiltration testing. There is no allegation that any fresenius device(s) malfunctioned or failed to perform as expected. Intradialytic hypotension is well-established as one of the leading complications of hd therapy. The device was repaired in the field and returned to service. An investigation of the product history records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

Contact from a hemodialysis clinic reported an adverse event with a patient while receiving hemodialysis treatment. It was reported that the patient¿s blood pressure dropped, was lethargic and subsequently moved to the icu and was given intravenous fluids. The patient condition reportedly improved. The clinic contact requested to have the dialysis machine evaluated. Additional information was solicited.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7459462
• MDR Text Key: 106581936
• Report Number: 2937457-2018-01151
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 2008T
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 04/25/2018 Patient Sequence Number: 1