MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008K2

Device Problems Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No parts were returned to the manufacturer for physical evaluation.The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A biomedical engineer (bme) from an in-center hemodialysis user facility reported evidence of excessive heat damage to an internal component of a 2008k2 hemodialysis (hd) machine.There was no patient connected to the machine at the time of the incident.The bme indicated that the unit was powered on after performing the cbe hardware upgrade.Upon powering up, the bme observed damage to resistor (r4) on the distribution board; the resistor was visibly burnt.The bme replaced the distribution board.The current repair status of the hd machine is not known.Although requested, no further information has been received from the user facility.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.The current repair status of the hd machine is not known.Although requested, no further information has been received from the user facility.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.In addition, the device history record (dhr) review confirmed the labeling, material, and process controls were within specification.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5843276
• MDR Text Key: 51767587
• Report Number: 2937457-2016-00816
• 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,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• 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
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2011
• 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