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

Model Number 190610

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2021

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 biomedical technician (biomed) reported to fresenius technical support (ts) that a 2008k2 hemodialysis (hd) machine would not power on.Reportedly, it had turned off when the staff attempted to put it into rinse mode, and it wouldnt turn back on.The machine was subsequently pulled from service for evaluation.When the biomed tried turning it on in the back room, they stated that nothing happened; not even the fan was making a noise.They attempted to resolve the issue by replacing the power supply assembly.The biomed used a power supply that was purchased from another vendor, svs dialysis.The biomed stated they purchase parts from svs because the prices are significantly cheaper.However, the biomed was also quick to note that these parts are not considered certified.The biomed stated the svs parts are not held to the same quality standards as some other suppliers.After installing the power supply from svs dialysis, when the biomed first turned the machine on they heard a snap, or a crack.They then saw smoke coming out of the back of the machine.The biomed immediately looked behind the machine and noticed a flame that looked to be approximately 1-inch tall.They were able to see this because the power supply was not locked in.The biomed stated the screws that go through the blood pump module were not put back in yet.The biomed slid the power supply out of the machine and blew out the flame.The smoke detector did not go off and the use of a fire extinguisher was not necessary.After examining the power supply, the biomed was able to identify the capacitor on the power control board as the source of the flame.The biomed stated the power control board is part of the power supply assembly.On the power control board, the biomed saw that the capacitor (c10) was cracked open across the width, and charred.The biomed was confident that the capacitor was what blew up.The biomed stated that the surrounding areas of the capacitor were charred/blackened.Ic4 looked charred, as did resistors 13, 14, 15, and 16.The connector that goes from the power control board to the power logic board was also burnt.No damage was identified on any other components.The biomed ordered and received a new power supply assembly from fresenius, but the part had not yet been installed.They anticipate that installing the new power supply assembly will resolve the issue.The 2008k2 hd machine, which was reportedly refurbished, had 8,898 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The biomed kept the power control board and stated that they would contact fresenius technical support to set up an rga for the part to be returned for failure analysis.The remaining power supply subcomponents were scrapped.A photo of the damaged power control board was provided for review.There was no patient involvement associated with the reported event.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical support (ts) that a 2008k2 hemodialysis (hd) machine would not power on.Reportedly, it had turned off when the staff attempted to put it into rinse mode, and it wouldn¿t turn back on.The machine was subsequently pulled from service for evaluation.When the biomed tried turning it on in the back room, they stated that nothing happened; not even the fan was making a noise.They attempted to resolve the issue by replacing the power supply assembly.The biomed used a power supply that was purchased from another vendor, svs dialysis.The biomed stated they purchase parts from svs because the prices are significantly cheaper.However, the biomed was also quick to note that these parts are not considered ¿certified¿.The biomed stated the svs parts are not held to the same quality standards as some other suppliers.After installing the power supply from svs dialysis, when the biomed first turned the machine on they heard a ¿snap¿, or a ¿crack¿.They then saw smoke coming out of the back of the machine.The biomed immediately looked behind the machine and noticed a flame that looked to be approximately 1-inch tall.They were able to see this because the power supply was not locked in.The biomed stated the screws that go through the blood pump module were not put back in yet.The biomed slid the power supply out of the machine and blew out the flame.The smoke detector did not go off and the use of a fire extinguisher was not necessary.After examining the power supply, the biomed was able to identify the capacitor on the power control board as the source of the flame.The biomed stated the power control board is part of the power supply assembly.On the power control board, the biomed saw that the capacitor (c10) was cracked open across the width, and charred.The biomed was confident that the capacitor was what ¿blew up¿.The biomed stated that the surrounding areas of the capacitor were charred/blackened.Ic4 looked charred, as did resistors 13, 14, 15, and 16.The connector that goes from the power control board to the power logic board was also burnt.No damage was identified on any other components.The biomed ordered and received a new power supply assembly from fresenius, but the part had not yet been installed.They anticipate that installing the new power supply assembly will resolve the issue.The 2008k2 hd machine, which was reportedly refurbished, had 8,898 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The biomed kept the power control board and stated that they would contact fresenius technical support to set up an rga for the part to be returned for failure analysis.The remaining power supply subcomponents were scrapped.A photo of the damaged power control board was provided for review.There was no patient involvement associated with the reported event.

Manufacturer Narrative

Additional information: h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical support (ts) that a 2008k2 hemodialysis (hd) machine would not power on.Reportedly, it had turned off when the staff attempted to put it into rinse mode, and it wouldn¿t turn back on.The machine was subsequently pulled from service for evaluation.When the biomed tried turning it on in the back room, they stated that nothing happened; not even the fan was making a noise.They attempted to resolve the issue by replacing the power supply assembly.The biomed used a power supply that was purchased from another vendor, svs dialysis.The biomed stated they purchase parts from svs because the prices are significantly cheaper.However, the biomed was also quick to note that these parts are not considered ¿certified¿.The biomed stated the svs parts are not held to the same quality standards as some other suppliers.After installing the power supply from svs dialysis, when the biomed first turned the machine on they heard a ¿snap¿, or a ¿crack¿.They then saw smoke coming out of the back of the machine.The biomed immediately looked behind the machine and noticed a flame that looked to be approximately 1-inch tall.They were able to see this because the power supply was not locked in.The biomed stated the screws that go through the blood pump module were not put back in yet.The biomed slid the power supply out of the machine and blew out the flame.The smoke detector did not go off and the use of a fire extinguisher was not necessary.After examining the power supply, the biomed was able to identify the capacitor on the power control board as the source of the flame.The biomed stated the power control board is part of the power supply assembly.On the power control board, the biomed saw that the capacitor (c10) was cracked open across the width, and charred.The biomed was confident that the capacitor was what ¿blew up¿.The biomed stated that the surrounding areas of the capacitor were charred/blackened.Ic4 looked charred, as did resistors 13, 14, 15, and 16.The connector that goes from the power control board to the power logic board was also burnt.No damage was identified on any other components.The biomed ordered and received a new power supply assembly from fresenius, but the part had not yet been installed.They anticipate that installing the new power supply assembly will resolve the issue.The 2008k2 hd machine, which was reportedly refurbished, had 8,898 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The biomed kept the power control board and stated that they would contact fresenius technical support to set up an rga for the part to be returned for failure analysis.The remaining power supply subcomponents were scrapped.A photo of the damaged power control board was provided for review.There was no patient involvement associated with the reported event.

Manufacturer Narrative

Correction: h6, h10 (photo evaluation inadvertently omitted by plant investigator) plant investigation: upon further review by the manufacturing plant, the reported complaint has been confirmed.Evaluation of the provided photo confirmed the reported issue of thermal damage to the power control board.

• 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; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 11600592
• MDR Text Key: 243310828
• Report Number: 2937457-2021-00567
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1