MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number CAR-500

Device Problem Defective Alarm (1014)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/14/2021

Event Type  malfunction  

Event Description

The patient was on continuous renal replacement therapy.The cycler suddenly stopped and alarmed, per report of the rn operating the device.The alarm was unable to be muted and unable to stop/re-start.The plug was pulled to stop the alarming, then re-inserted the plug and attempted re-start, but alarm resumed.Unable to return blood to the patient and he lost 310 ml of blood and required a transfusion later in the day for low hematocrit.Three additional set-up were attempted with the same cartridge lot # but none allowed rn to program or prime.A different lot number cartridge was then attempted, and it was set up and running without issue.Lot # 01078004 was the number for the 1st 3 setups.Lot # 10378017 worked.

• Brand Name: NXSTAGE CARTRIDGE EXPRESS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 12074647
• MDR Text Key: 258633879
• Report Number: 12074647
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAR-500
• Device Lot Number: 01078004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Weight: 97