PRISMAFLEX 7.20 955542

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for PRISMAFLEX 7.20 955542 manufactured by Gambro Ab.

Event Text Entries

[183902879] Patient on crrt, circuit overdue for change by 1 day (last changed tuesday (b)(6), it is two days later. Alarm for "self test failed" went off, giving rn two choices: retest or disconnect. Attempted to retest 3 times, but circuit quickly alarmed for same reason. When option to disconnect was chosen, there was no option to return blood. This is a critically ill pt with pre b cell all, status post sacrococcygeal teratoma (sct) in the icu for sepsis, veno-occlusive disease (vod), acute kidney injury (aki), and respiratory failure. She is on norepinephrine for blood pressure support, and receives multiple blood products each shift. Her latest hct = 29. Circuit had not had any such alarms this shift, nor were any passed on during report. We had planned a circuit change this afternoon already, so circuit stopped itself at a convenient time. However, unable to return blood - pt lost 187ml blood due to this. I-stat gas shows hct 24. No changes in patient status, still on norepinephrine, no increase in oxygen requirement or physical symptoms. Troubleshoot equipment. Could this have been avoided had circuit been changed on time, or would it not have made a difference?
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9847294
• MDR Report Key: 9847294
• Date Received: 2020-03-18
• Date of Report: 2020-02-12
• Date of Event: 2020-02-01
• Report Date: 2020-02-12
• Date Reported to FDA: 2020-02-12
• Date Reported to Mfgr: 2020-03-18
• Date Added to Maude: 2020-03-18
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PRISMAFLEX
• Generic Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Product Code: KDI
• Date Received: 2020-03-18
• Model Number: 7.20
• Catalog Number: 955542
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GAMBRO AB
• Manufacturer Address: ONE BAXTER PARKWAY DEERFIELD IL 60015 US 60015

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-18