MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problem False Alarm (1013)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2020

Event Type  malfunction  

Event Description

Within the first hour of continuous crrt, the loss/gain limit on the was at 160 ml/hr (set to 200 ml/3 hrs) and counting upward.Nothing was touching the scales and the effluent line was adjusted.The effluent scale was calibrated with the assistance of icon representative.Low end of calibration read -4 with upper end =3.The numbers were not increasing to reach the loss/gain limit.The patient vital signs and fluid balance remained stable.Over time, the loss/gain limit was not reached and gradually reset to +/-10.Patient treatment was completed.Patient vital signs and fluid loss remained stable.Manufacturer response for crrt pump with effluent scale, (brand not provided) (per site reporter).The calibration of the effluent scale was within standard.Effluent scale alarm is very sensitive, and a false alarm was most likely triggered by vibration of the building, air currents from heating/cooling bents, or other environmental factors.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO INDUSTRIES; one baxter parkway; deerfield IL 60015
• MDR Report Key: 10108687
• MDR Text Key: 193374287
• Report Number: 10108687
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2920 DA
• Patient Weight: 38