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

Catalog Number	107142
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• MDR Report Key: 8868818
• Report Number: 8010182-2019-00165
• Device Sequence Number: 2000835
• Product Code: KDI
• UDI-Device Identifier: 07332414069315
• UDI-Public: (01)07332414069315
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2020
• Report Date (Section F): 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Distributor Facility Aware Date: 07/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 08/30/2019; 12/17/2020
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/13/2019; 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRISMAFLEX CONTROL UNIT; PRISMAFLEX CONTROL UNIT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Weight: 84
• Date Report Sent to FDA: 08/07/2019