MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	191128
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
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 biomedical technician (biomed) contacted fresenius technical support (ts) to request a replacement blood pump module for a 2008t hemodialysis (hd) machine.It was reported that the blood pump rotor had cut into the blood tubing segment during a patient¿s treatment, resulting in approximately 2 ml of blood loss.At first, an air detector alarm sounded, and the staff then noticed air in the blood lines.The blood pump was stopped, and the blood tubing was noted to be damaged.The patient was moved to another machine where they completed their treatment.The biomed told ts that the event did not result in any patient harm or injury.Multiple attempts to obtain additional information have been performed without success.Thus far, no further information has been provided.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the blood pump module was returned to the manufacturer for physical evaluation.The blood pump was returned without the rotor or the tubing retaining clamp.During visual examination of the returned part, no physical damage was found.A ¿known good¿ rotor and a tubing retaining clamp were installed onto the blood pump for testing.Next, a ¿known-good¿ blood line with dialyzer was inserted into the blood pump module and was submerged in water for testing.There were no problems during the initial power up.The blood pump module functioned properly during dialysis without any alarms or failures.The blood line did not leak during testing and no punctures were found on the blood line after use.The self-test program was completed without failures.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The device performed as designed and an associated cause could not be determined.

• Brand Name: 2008T HD SYS. W/O CDX BLUE STAR
• 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
• MDR Report Key: 11087079
• Report Number: 2937457-2020-02346
• Device Sequence Number: 14150226
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2021

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: 191128
• Device Catalogue Number: 191128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Device Age: MO
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 04/07/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/05/2021; 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1