MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX HF1400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 107142

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Air Embolism (1697)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during patient treatment with a prismaflex hf1400 set, the arterial luer lock connector had broke off, and was stuck inside the y-connector that was connected to normal saline.This resulted in air entering the patient.The patient presented with shortness of breath and was placed on a ventilator to relieve the symptoms.The patient has recovered with no lasting effects and is now being treated with ordinary dialysis.No additional information is available.

Manufacturer Narrative

Additional information: the actual device was received for evaluation.Visual inspection revealed that the cone of the male luer connector of the access line was broken inside the priming accessory (y-line).The y-connector, which is intended for use during priming only, was not removed from the hf1400 set when connecting the patient to the prismaflex system.Per the prismaflex hf1400 instruction for use, ifu, the operator should "use the set by following the detailed on-line instructions provided by the prismaflex control unit".After completion of the priming procedure, the prismaflex graphical user interface clearly states: "disconnect access line from y-line, connect to red luer lock on catheter (or other blood access)", i.E.The y-connector is not to be connected between the access line and the catheter.Leaving the y-connector connected during patient treatment is considered user error.The reported condition was verified.The cause of the condition was not determined.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: removal of information in section f related to importer - the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).

• Brand Name: PRISMAFLEX HF1400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• MDR Report Key: 8868818
• MDR Text Key: 153526628
• Report Number: 8010182-2019-00165
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414069315
• UDI-Public: (01)07332414069315
• Combination Product (y/n): N
• PMA/PMN Number: K042938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2019,12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 107142
• Device Lot Number: 19A2902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2019
• Distributor Facility Aware Date: 07/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX CONTROL UNIT; PRISMAFLEX CONTROL UNIT
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 84