MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. DIALYSATE SACK WITH CONCENTRATE (SAK-302); DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Lot Number 11279186

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Rash (2033); Dizziness (2194)

Event Date 02/15/2023

Event Type  Injury  

Event Description

Describe event, problem, or product use error: this was the patient's first and only exposure to nxstage hemodialysis.Patient had previously received a regular course of dialysis on fresenius 2008t dialysis system.Within one minute of starting dialysis, patient reported "my back itches".The nurse ended dialysis treatment after 3 minutes for significant reduction in blood pressure.Patient initially answered negative for symptoms of hypotension "i feel fine except for the itching".After dialysis termination was complete, patient reported dizziness, and developed hives.In approximately 5 minutes, the patient had improved to normal blood pressure, with residual dizziness and hives had faded.Lab specimens collected were not to diagnose a condition or monitor treatment, but rather assess the dialysis for contaminants and organisms.All pre-treatment tests and checks of the dialysis formula (automatic conductivity test in range & chlorine/chloramine levels zero) and circuit pressures passed.Post-incident lab specimens were collected from the dialysis purification system and final dialysis formula that the patient was exposed to.All lab results were in acceptable ranges for electrolytes, colony count, and endotoxin.Patient had no known allergies prior to this incident.

• Brand Name: DIALYSATE SACK WITH CONCENTRATE (SAK-302)
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.
• MDR Report Key: 16505279
• MDR Text Key: 311013181
• Report Number: MW5115559
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/15/2023
• Device Lot Number: 11279186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White