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

Model Number	190610
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility certified clinical hemodialysis technician (ccht) reported after treatment began, the technician noticed that the tubing was pinched in the blood pump rotor area, causing a blood spill and creating a level detector (air in blood) alarm.Treatment was terminated and the machine was placed out of service.The patient was moved to another machine, beginning a new setup and treatment resumed until completed.It was reported a blood line was punctured.The patient was moved to another machine to begin and complete dialysis treatment.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.Upon follow-up, the ccht stated the blood pump rotor of the machine, a fresenius 2008k2 machine, was coming off and caused a blood leak to occur.The ccht stated the rotor guide sleeves (around the pins) were coming off and cut the blood pump tubing.The machine was pulled from service pending replacement of the blood pump rotor.The rotor was the original to the machine.The ccht stated that fresenius bloodlines were used for treatment and confirmed that there were no defects or damage seen on the machine or bloodline prior to the event.The ccht was unable to report how long into treatment the event occurred.Per ccht treatment was immediately halted and the patient¿s blood was not returned.The bmt stated the estimated blood loss was approximately 10 ml.Immediately following the event, the patient was re-setup with new supplies on a different machine where the patient was able to complete treatment.The ccht confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The ccht stated the component was no longer available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Investigation determines that there was causal relationship between the objective evidence and the alleged event; the alleged event is confirmed.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 able to be confirmed.
Event or Problem Description
A user facility certified clinical hemodialysis technician (ccht) reported after treatment began, the technician noticed that the tubing was pinched in the blood pump rotor area, causing a blood spill and creating a level detector (air in blood) alarm.Treatment was terminated and the machine was placed out of service.The patient was moved to another machine, beginning a new setup and treatment resumed until completed.It was reported a blood line was punctured.The patient was moved to another machine to begin and complete dialysis treatment.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.Upon follow-up, the ccht stated the blood pump rotor of the machine, a fresenius 2008k2 machine, was coming off and caused a blood leak to occur.The ccht stated the rotor guide sleeves (around the pins) were coming off and cut the blood pump tubing.The machine was pulled from service pending replacement of the blood pump rotor.The rotor was the original to the machine.The ccht stated that fresenius bloodlines were used for treatment and confirmed that there were no defects or damage seen on the machine or bloodline prior to the event.The ccht was unable to report how long into treatment the event occurred.Per ccht treatment was immediately halted and the patient¿s blood was not returned.The bmt stated the estimated blood loss was approximately 10 ml.Immediately following the event, the patient was re-setup with new supplies on a different machine where the patient was able to complete treatment.The ccht confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The ccht stated the component was no longer available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Correction: h6 device component code.
Event or Problem Description
A user facility certified clinical hemodialysis technician (ccht) reported after treatment began, the technician noticed that the tubing was pinched in the blood pump rotor area, causing a blood spill and creating a level detector (air in blood) alarm.Treatment was terminated and the machine was placed out of service.The patient was moved to another machine, beginning a new setup and treatment resumed until completed.It was reported a blood line was punctured.The patient was moved to another machine to begin and complete dialysis treatment.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.Upon follow-up, the ccht stated the blood pump rotor of the machine, a fresenius 2008k2 machine, was coming off and caused a blood leak to occur.The ccht stated the rotor guide sleeves (around the pins) were coming off and cut the blood pump tubing.The machine was pulled from service pending replacement of the blood pump rotor.The rotor was the original to the machine.The ccht stated that fresenius bloodlines were used for treatment and confirmed that there were no defects or damage seen on the machine or bloodline prior to the event.The ccht was unable to report how long into treatment the event occurred.Per ccht treatment was immediately halted and the patient¿s blood was not returned.The bmt stated the estimated blood loss was approximately 10 ml.Immediately following the event, the patient was re-setup with new supplies on a different machine where the patient was able to complete treatment.The ccht confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The ccht stated the component was no longer available to be returned for manufacturer evaluation.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16403828
• Report Number: 0002937457-2023-00239
• Device Sequence Number: 14793039
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K994267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 03/20/2023; 03/22/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 03/21/2023; 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008K2 MACHINE; FRESENIUS 2008K2 MACHINE; FRESENIUS 2008K2 MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Sex: Unknown