MAUDE Adverse Event Report: GAMBRO INDUSTRIES BAXTER PLASMAFLEX CRRT MEMBRANE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number M100 SET

Device Problems Break (1069); Fluid/Blood Leak (1250); Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2020

Event Type  Injury  

Event Description

Pt was on crrt; when rn who was running the crrt changed the filter and reconnected it to the pt's vas cath, she saw blood pouring from the blue port of the vas cath where the crrt blue line was connected.A second nurse checked the connection and line and it appeared to be connected correctly.The machine was re-started and blood began coming out again.They disconnected the crrt filter lines from the vas cath and dark blood was seen in the hub of the vas cath.It was thought it was a clot and attempted to aspirate from the blue port, then noted the luer lock wouldn't attach to the vas cath hub.It was then seen that the male prong on the crrt filter access line was missing and was broken off in the vas cath.Nurse was able to remove the red port from the vas cath and hep lock the line but couldn't hep lock the blue port.The pt did not experience harm though it was a serious close call.Death on (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: BAXTER PLASMAFLEX CRRT MEMBRANE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO INDUSTRIES; meyzieu cedex, lioneal terray 69883 ; FR 69883
• MDR Report Key: 10016941
• MDR Text Key: 189715647
• Report Number: MW5094325
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: M100 SET
• Device Lot Number: 19C0608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 83