MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	190895
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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 biomedical technician (biomed) reported to technical support that a fresenius 2008t hemodialysis (hd) machine had an ¿act.Blood pump failed¿ message that appeared in the last three minutes of a patient¿s treatment.The biomed stated there was no patient harm, but indicated the event resulted in minor blood loss.Blood from the arterial line was returned, however, blood from the venous line had clotted and could not be returned.The patient¿s estimated blood loss was said to be 200 ml.The patient did not complete their treatment.However, there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.Following the event, the machine was pulled from service for evaluation.The biomed could not duplicate the alarm.They ran multiple tests, including a three-hour mock treatment with saline bags to simulate a real treatment, and there were no issues.The alarm did not reoccur during the mock treatment and the biomed did not need to replace any parts on the machine.Upon follow-up, it was confirmed that the machine was ready to be returned to service.As no parts were replaced, a sample was not available to be returned for evaluation.
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.
Event or Problem Description
A biomedical technician (biomed) reported to technical support that a fresenius 2008t hemodialysis (hd) machine had an ¿act.Blood pump failed¿ message that appeared in the last three minutes of a patient¿s treatment.The biomed stated there was no patient harm, but indicated the event resulted in minor blood loss.Blood from the arterial line was returned, however, blood from the venous line had clotted and could not be returned.The patient¿s estimated blood loss was said to be 200 ml.The patient did not complete their treatment.However, there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.Following the event, the machine was pulled from service for evaluation.The biomed could not duplicate the alarm.They ran multiple tests, including a three-hour mock treatment with saline bags to simulate a real treatment, and there were no issues.The alarm did not reoccur during the mock treatment and the biomed did not need to replace any parts on the machine.Upon follow-up, it was confirmed that the machine was ready to be returned to service.As no parts were replaced, a sample was not available to be returned for evaluation.

• Brand Name: 2008T GEN 2 BIBAG WITHOUT CDX
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 12200321
• Report Number: 2937457-2021-01523
• Device Sequence Number: 1494207
• Product Code: KPO
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K121341
• 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
• Report Date (Section B): 08/09/2021

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: 190895
• Device Catalogue Number: 190895
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 73