MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. PUREFLOW DIALYSATE CONCENTRATE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM

Model Number	SAK-304
Health Effect - Clinical Codes	Fatigue (1849); Unspecified Infection (1930); Pneumonia (2011); Seizures (2063); Weakness (2145)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release.There is no information to indicate that a malfunction occurred.Adverse reactions are known risks of hemodialysis.Infection and pneumonia are known contributing factors to abnormal lactate levels.Biocompatability has been established.
Event or Problem Description
A report was received on (b)(6) 2019 from a nurse stating the (b)(6) female with unspecified comorbidities, experienced fatigue, silent seizures, felt jittery, clammy and weak following hemodialysis treatments with the product on multiple unspecified days.Nxstage therapy was discontinued on (b)(6) 2019.Additional information received on 07 aug 2019 from the nurse revealed the patient was hospitalized on (b)(6) 2019 with out of range lactate levels (nos), pneumonia and a catheter infection.The patient recovered without sequelae and remained hospitalized for an unrelated hip replacement, date of discharge not available.

• Brand Name: PUREFLOW DIALYSATE CONCENTRATE
• Common Device Name: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 8902549
• Report Number: 3003464075-2019-00040
• Device Sequence Number: 16676392
• Product Code: FKR
• UDI-Device Identifier: M535SAK3040
• UDI-Public: +M535SAK3040/$$032190479197A
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/16/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/13/2021
• Device Model Number: SAK-304
• Device Catalogue Number: SAK-304
• Device Lot Number: 90479197
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/16/2019
• 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: Hospitalization
• Patient Age: 79 YR
• Patient Weight: 68
• Date Report Sent to FDA: 01/01/2005