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

Catalog Number	190895
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
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 nurse reported that a fresenius 2008t machine had blood rising to the p-ven port during the patient¿s hemodialysis treatment.The machine sounded a venous pressure alarm.The venous pressure was calibrated but continued to drop when they tried to pump.The patient was moved to another machine and did not experience any adverse effects as a result of this incident.Additional information was requested, however, to date not provided.
Additional Manufacturer Narrative
Correction: upon further investigation, it was determined that the event reported on this mdr was reported incorrectly as there was no blood loss reported.There will be no further updates on mfr#: 2937457-2019-03257.
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 regional equipment specialist (res).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.

• 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: 9245064
• Report Number: 2937457-2019-03257
• Device Sequence Number: 409493
• Product Code: KPO
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 190895
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/04/2019; 11/12/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/05/2019; 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1