MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	190630
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
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
It was reported to fresenius that the blood pump on a 2008k2 machine made an incision in the tubing of the bloodlines during a patient's hemodialysis (hd) treatment resulting in blood loss.Additional information was obtained during follow-up.The patient was approximately 2 hours into treatment when the machine alarmed with an air detection message.The registered nurse (rn) removed air from the venous chamber of the bloodlines to continue treatment but the message reoccurred.Blood was visually observed to be dripping.Upon inspection an incision was identified in the tubing of the bloodlines located near the blood pump.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient's estimated blood loss (ebl) could not be provided.The patient was able to complete treatment on a different machine with new supplies (manufacturer unknown).The machine was removed from service following the event and a fresenius field service technician (fst) was called on site.The fst determined the rotors of the blood pump were worn and bent.The blood pump was replaced to resolve the reported issue.The machine has been returned to service.
Event or Problem Description
It was reported to fresenius that the blood pump on a 2008k2 machine made an incision in the tubing of the bloodlines during a patient's hemodialysis (hd) treatment resulting in blood loss.Additional information was obtained during follow-up.The patient was approximately 2 hours into treatment when the machine alarmed with an air detection message.The registered nurse (rn) removed air from the venous chamber of the bloodlines to continue treatment but the message reoccurred.Blood was visually observed to be dripping.Upon inspection an incision was identified in the tubing of the bloodlines located near the blood pump.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient's estimated blood loss (ebl) could not be provided.The patient was able to complete treatment on a different machine with new supplies (manufacturer unknown).The machine was removed from service following the event and a fresenius field service technician (fst) was called onsite.The fst determined the rotors of the blood pump were worn and bent.The blood pump was replaced to resolve the reported issue.The machine has been returned to service.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer which prevented the completion of a physical 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 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.Objective evidence was found during the completion of the manufacturer investigation indicating a product problem, thus the complaint is confirmed.

• Brand Name: 2008K2 MACHINE, SHORT CAB, OLC/DP, HP
• 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: 16702819
• Report Number: 0002937457-2023-00531
• Device Sequence Number: 14356149
• Product Code: KDI
• UDI-Device Identifier: 00840861100866
• UDI-Public: 00840861100866
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/04/2023

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: 190630
• Device Catalogue Number: 190630
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/04/2023
• 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
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 76 KG