MAUDE Adverse Event Report: GAMBRO DASCO SPA PRISMASATE; DIALYSATE CONCENTRATE FOR HEMODIALYSIS(LIQUID OR POWDER)

Lot Number 764583

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

The device was discarded and not returned for analysis.The investigation is ongoing.

Event Description

A physician reported that a patient undergoing continuous renal replacement therapy (crrt) which included prismasate bk0/3.5.The prismasate was used off label as the replacement solution.The crrt machine, blood lines and filter used in this event are not manufactured or distributed by baxter.Reportedly, the patient had a blood loss when the filter clotted and they were unable to return the blood in the extracorporeal circuit back to the patient.The patient's hemoglobin level decreased from 8 g/dl to 5 g/dl and the patient was transfused with a unit of blood.The date of the event is unknown therefore; the date in date of event is an estimated date.

• Brand Name: PRISMASATE
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS(LIQUID OR POWDER)
• Manufacturer (Section D): GAMBRO DASCO SPA; sondalo, ; IT
• Manufacturer Contact: maddalena guicciardi ; via stelvio, 23035; sondalo, ; IT ; 342801515
• MDR Report Key: 6205876
• MDR Text Key: 63311605
• Report Number: 3003591774-2016-00005
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 764583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2016
• Distributor Facility Aware Date: 11/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2016
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other