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

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

Patient Problems Hypoglycemia (1912); Weakness (2145)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in progress.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

It was reported that a hemodialysis patient was hospitalized for low blood sugar and a generalized feeling of weakness coincident with hemodialysis treatment.It was originally reported that the patient was hospitalized for complications related to the patient¿s diabetes.Upon follow up with the patient¿s nurse, it was further specified that the patient was hospitalized for low blood sugar.The patient was about midway through hemodialysis therapy when they began to experience symptoms of hypoglycemia.Treatment was cancelled and 911 was contacted.There was no reported blood loss as a result of the patient ending treatment early.Treatment during the patient¿s hospitalization was unknown.The peritoneal dialysis registered nurse believed that the patient continued with hemodialysis therapy throughout their hospitalization.The exact cause for the low blood sugar was unknown.On an unspecified date, the patient recovered from the event and was discharged from the hospital.Once discharged, the patient continued with in-center hemodialysis therapy.Additional information was requested but was unavailable.

Manufacturer Narrative

A clinical investigation was performed to identify a causal relationship between the patient's hemodialysis dialysis (hd) treatment and the reported adverse event.Based on the provided information, there is no documentation that shows a causal relationship between this event and the use of the 2008k machine for hd treatment.Additionally, there is no allegation or indication of a device malfunction that could have caused or contributed to the reported event.Although a direct causal relationship could not be confirmed, a temporal relationship between the patient's hd treatment and the adverse event remains.Should additional new information be made available this clinical investigation will be reevaluated.Plant investigation: the device was not returned to the manufacturer for physical evaluation, and the serial number could not be obtained.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.

• Brand Name: 2008K 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: 7275674
• MDR Text Key: 100233604
• Report Number: 2937457-2018-00484
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 02/19/2018
• 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): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 67