MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN-2008K MACHINE

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

Patient Problems Death (1802); Respiratory Failure (2484)

Event Date 07/01/2017

Event Type  Death  

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and a serial number could not be ascertained.As neither a device history record review nor a physical evaluation could 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.A clinical review was performed to identify the necessity of performing a clinical investigation for the reported incident.Based on the provided information, there is currently no allegation or documentation that suggests that a fresenius device or product caused or contributed to the patient¿s death.As there is currently no causal relationship between the patient¿s passing and their hemodialysis treatment, a clinical investigation is not warranted.Should additional information become available, the need for a clinical investigation will be reevaluated.

Event Description

It was reported that a hemodialysis patient passed away from respiratory failure.Leading up to their passing, the patient was performing hemodialysis in an unspecified hospital.The patient was scheduled to be transferred to a clinic for further in-center hemodialysis treatments when they passed away.It was not reported if the patient was connected to a hemodialysis machine at the time of death.The exact date of the patient's passing was not provided.Furthermore, it is currently unknown if a fresenius machine was being utilized for hemodialysis treatments.Additional follow up attempts with the patient¿s peritoneal dialysis registered nurse were unsuccessful in obtaining additional information related to the event.

• Brand Name: 2008K HEMODIALYSIS MACHINE
• 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: 7340913
• MDR Text Key: 102453850
• Report Number: 2937457-2018-00777
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN-2008K MACHINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/26/2018
• 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; Hospitalization
• Patient Age: 81 YR