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

Catalog Number 190766

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

Patient Problem Death (1802)

Event Date 04/02/2018

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility nurse manager reported a patient who coded during hemodialysis (hd) treatment.The patient was in an acute facility and was chronically ill and in critical condition.The patient coded during treatment and treatment was discontinued.The nurse manager reported that the patient recovered from the event, however, subsequently passed away later that day on (b)(6) 2018.The nurse manager stated that the patient was not a chronic dialysis patient and that dialysis therapy was used as a last attempt to help the patient.The machine was sequestered after the event.A fresenius regional equipment specialist (res) was called onsite to perform a machine evaluation per hospital policy.The nurse manager stated that there was no allegation of product deficiency or malfunction on or against the machine or any fresenius device(s).The res technician verified operation of the machine and the machine was found to be functioning as per specification and functional tests performed.The machine was placed back in service.Additional information regarding the patient and the event was requested, however, not provided by the facility.

Manufacturer Narrative

Additional information: clinical investigation clinical investigation: a temporal relationship exists between the hemodialysis (hd) therapy utilizing the 2008t hd machine and the adverse event of death.Based on the information available, the etiology of the hospitalization and eventual expiration of the patient is unknown.It is known however, that end stage renal disease (esrd) patients receiving renal replacement therapy (rrt) have a higher mortality rate.Therefore, based on the information available, causality cannot be determined.There is no evidence or documentation in the file which establishes a causal relationship between the event of death and the 2008t hd machine.Additionally, there is no report of a malfunction or of the machine failing to perform as expected.This is further emphasized by the clinical manager's statement in which it was stated there were no allegations being levied against the machine.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res) due to the reported event.The res evaluated the machine.The machine underwent functional checks and all tests found the unit to be functioning within specification and no repairs were made.A records review was performed on the reported device serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformance's, or any associated rework during the manufacturing process which could be related to the reported event.Additionally, a review of the device history record (dhr) confirmed the results of the in-progress and final quality control (qc) testing met all the requirements.The investigation into the cause of the reported problem was not able to be confirmed.

• 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: 7448973
• MDR Text Key: 106131874
• Report Number: 2937457-2018-01119
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2018

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: 190766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 04/26/2018; 08/23/2018
• Supplement Dates FDA Received: 05/14/2018; 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2017
• 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