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

Model Number 190610

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility representative reported to fresenius (b)(4) that a fresenius 2008k2 hemodialysis (hd) machine would not power on.The issue was observed while preparing the machine prior to patient use.A fresenius (b)(4) technician was scheduled to service the reported machine.Upon follow up with the biomedical technician ((b)(4)), its reported during a visual inspection the switch for the power supply was found to be melted.The (b)(4) indicated that the switch melted near the cable connections for the power supply and the power control board and it was most likely caused by a power surge at the hospital.The switch was replaced and the machine was able to power on.The machine was left in functioning order after completing a rinse and some tests.There are no samples available for evaluation.This report was received from fresenius (b)(6).

Manufacturer Narrative

Corrected information: date rec¿d by mfr: inadvertently omitted (transcription error).

Manufacturer Narrative

Method, result codes; removing statement indicating on-site service (transcription error) plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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 non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The manufacturer investigation into the cause of the reported problem was not able to identify nor confirm any potential manufacturing related causes.A definitive conclusion regarding the complaint incident cannot be reached.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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 non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The manufacturer investigation into the cause of the reported problem was not able to identify nor confirm any potential manufacturing related causes.A definitive conclusion regarding the complaint incident cannot be reached.Based on the service performed on site the electrical problem was confirmed.

• Brand Name: 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 11121417
• MDR Text Key: 225244647
• Report Number: 2937457-2021-00023
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• PMA/PMN Number: K153449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190610
• Device Catalogue Number: 190618
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1