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

Model Number 113081

Device Problems Device Displays Incorrect Message (2591); Operating System Becomes Nonfunctional (2996)

Patient Problem No Code Available (3191)

Event Date 03/17/2017

Event Type  malfunction  

Event Description

Prismaflex dialysis pump in use for crrt therapy.There were frequent "access pressure too negative " alarms due to patient movement.After several minutes the pump alarmed "access pressure too positive".Nurse attempted to speed up blood flow to get pump to run and to put through self-test to clear alar.She was unable to do either.Pump continued to alarm "access pressure too positive" and then pump froze with alarm screen up.Unable to use touch screen buttons or return blood to patient.Nurse was unable to unload dialysis set from machine due to frozen screen.Customer support was able to talk through issues to unload the set.Existing ways to trouble shoot include self-testing after removing and replacing pod on machine, but this can only be done once before entire set must be taken down.New pump was primed and therapy reinitiated.Patient required blood after treatment.Hemoglobin was at 6.3 when therapy initiated.Per site reporter: faulty diaphragm in the pressure pod.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO AB; 9540 maroon cir fl 4; englewood CO 80112
• MDR Report Key: 6633455
• MDR Text Key: 77313852
• Report Number: 6633455
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 113081
• Device Catalogue Number: 113081
• Other Device ID Number: DIALYSIS SET 16E2160 EXP 5/1/
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 17