MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT GRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number	0FD2251-3B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/06/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.(b)(4).
Event or Problem Description
A healthcare professional at a user facility reported that a patient passed away following treatment on a fresenius 2008t hemodialysis (hd) machine.Prior to treatment, the patient had a recorded blood pressure of 125/78 and a pulse of 84 beats per minute.The patient¿s respiratory measurement was 18.The patient initiated treatment via a right tunneled jugular catheter without complaint at about 15:36.The patient received dialysate via a central feed.Thirty minutes into treatment, the patient was reported to be resting comfortably.At about 16:27, the patient was administered doses of mircera (50mcg, ivp), venofer (100mg, ivp), and hectorol (2.0mcg, ivp).Approximately three minutes later, the patient reported that they were not feeling well and were unable to breathe.The patient became pale, diaphoretic and unresponsive.Treatment was discontinued.The user facility called 911 and the patient coded.The automated external defibrillator detected no rhythm and three rounds of cpr were performed.The ambulance arrived and the patient was transported to the hospital emergency room.The patient subsequently passed away.Upon follow up with the user facility, it was noted that there were no malfunctions or alarms during the patient¿s hd treatment.The cause of the patient¿s death was unknown and the patient¿s family declined an autopsy.The 2008t hd machine was removed from service for an evaluation by the on-site biomedical technician (biomed).The machine passed all functional tests and no repairs were required.The machine was returned to service.No malfunction of any fresenius products in use during the hd treatment was alleged, observed, or identified prior to, during, or following the event.The dialyzer is not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.No samples of the acid/bicarb in use during the treatment are available for analysis.
Additional Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer for physical evaluation and the lot number was not provided.Distribution records were reviewed to identify potential lots of this product shipped to the customer for the three (3) month time frame which immediately preceded the event.The entire set of lots have been sold and distributed.Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformances during the manufacturing process.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: GRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): OREGON MANUFACTURING PLANT; 750 n lallendorf road; oregon OH 43616
• MDR Report Key: 6950589
• Report Number: 3005162618-2017-00014
• Device Sequence Number: 1325143
• Product Code: KPO
• UDI-Device Identifier: 00840861101535
• UDI-Public: 00840861101535
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K030497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0FD2251-3B
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 10/15/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 97