MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS,; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008K2

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A fresenius regional equipment specialist (res) was called onsite to repair a 2008k2 hemodialysis (hd) machine that reportedly had no power and could not be powered on.There was no patient connected to the machine at the time of the incident.No harm to any patients, staff, or any other individual occurred as a result of this event.The res found that power plug sparked when plugged into the hospital's electrical outlet.No damage to the power supply or the power plug was observed.No burn damage was visible on the power plug.The res reseated the power supply cable to resolve the issue.Functional testing performed by the res confirmed that the system was operating properly.No parts are available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The 2008k2 hemodialysis machine was evaluated at the facility by the fresenius regional equipment specialist (res).The res found that power plug sparked when plugged into the hospital's electrical outlet.No damage to the power supply or the power plug was observed.No burn damage was visible on the power plug.The res reseated the power supply cable to resolve the issue.Functional testing performed by the res confirmed that the system was operating properly.No parts were available to be returned to the manufacturer for evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the labeling, material, and process controls were within specification.The investigation into the cause of the reported problem was able to confirm the failure mode.The res confirmed that the power plug sparked when plugged into the hospital¿s electrical outlet.Therefore, the complaint has been deemed confirmed.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS,
• 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: 6508532
• MDR Text Key: 73346915
• Report Number: 2937457-2017-00273
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 2008K2
• Device Catalogue Number: 190610
• Other Device ID Number: 00840861100859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2009
• 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