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

Model Number HF1000

Device Problems Inadequate Filtration Process (2308); Pressure Problem (3012); Application Program Problem: Medication Error (3198)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/25/2023

Event Type  malfunction  

Event Description

Event 1: patient a currently on continuous renal replacement therapy (crrt).The prismaflex hf1000 (lot #: 22f0092) clot off in 2-6 hours after initiating treatment.The clotting of the prismaflex hf1000 haemofilter decreased therapy time, filtration and removal of excess fluid.Event 2: patient b is on crrt.At shift change, the crrt machine began alarming high filter pressures.The filter was a new filter started 30 minutes prior to event.All the lines were followed to ensure no kinking and all in screen prompts for trouble shooting were followed.Eventually nurse had to change the filter out.Nurse was able to return the blood.Filter is prismaflex hf100 (lot #: 22f0092).The machine ran for approximately 1 1/2hrs before giving the same error message.The filter and the machine were again trouble shot to no avail.Nurse was forced to change filters again but this time the machine would not return the blood in the filter approximately 180ml.Nurse changed machines and filters again using the same above referenced lot # and was successful in running the remaining shift and thru dayshift.Later that day, the filter clotted off and had to be changed.In attempting to restart the crrt, a filter with (lot #: 22f0092 was placed but kept giving fault errors when attempting to prime.This filter was discarded and another filter was obtained and was successful in priming and re-starting crrt.There were a total of 3 filters that were faulty for this patient alone with one of which the patient lost approximately 180ml of blood.Event 3: crrt filter hf1000 (lot #: 22f0092) clotted 5 times in 24 hours ¿ event reports with harm to patient c.Event 4: crrt clotted off.The crrt machine could not return blood to patient d, doctor notified.No orders placed.Vas cath central venous line did not clot off.But filter clotted off.

• Brand Name: PRISMAFLEX SET
• 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: 16395952
• MDR Text Key: 309759337
• Report Number: 16395952
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HF1000
• Device Catalogue Number: 107140
• Device Lot Number: 22F0092
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 127 KG