MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN-2008K2 MACHINE

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

Patient Problems Pain (1994); Numbness (2415)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hemodialysis (hd) therapy utilizing the 2008k2 machine and the adverse event(s) of numbness, pain and vascular damage which required hospitalization and surgical intervention.The etiology of the event(s) is attributed to the over-inflation of a blood pressure cuff; however, the cause of the over-inflation is unknown; therefore, no causality can be fully established.Over-inflation of a blood pressure cuff has the potential to cause injury if not properly monitored.Based on the limited information available, the 2008k2 machine cannot be disassociated from the event(s).There are no treatment records available for review, and the machine was not returned to the manufacturer for functional compliance testing.It cannot be confirmed whether or not the machine malfunctioned with the information available.As such, a possible causal or contributory role in the patient¿s adverse event(s) cannot be excluded.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that the blood pressure cuff on a fresenius hemodialysis (hd) machine over inflated, causing the patient to sustain an injury to the veins on their right arm on (b)(6) 2018.The patient was subsequently hospitalized and suffered from severe pain and numbness in their hand.The patient underwent surgery to repair the damaged vein in their arm.The patient was hospitalized (b)(6) 2018.Additional information was requested, however to date not provided.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.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: 2008K2 MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8283341
• MDR Text Key: 134281271
• Report Number: 2937457-2019-00283
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN-2008K2 MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention