MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M100 SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 106697

Device Problems Break (1069); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the provided pictures did not identify any issues or defects associated with the set.The reported condition could not be verified through evaluation of the returned photographs.Additional recommended instruction is provided with this device for how to connect the female luer lock and the male luer.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.

Event Description

It was reported that after continuous renal replacement therapy (crrt) with a prismaflex m100 set was performed, plastic in a non-baxter catheter access line was observed.Treatment was ended without blood restitution.It was reported the operator was unable to disconnect the return line of the set and the catheter after crrt.Several attempts with metal hemostats were performed to loosen the connection between the access line and catheter.After, the operator disconnected the access line, plastic from access male luer lock lodged into the catheter was observed.Subsequently the catheter was removed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLEX M100 SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8341187
• MDR Text Key: 139035657
• Report Number: 8010182-2019-00047
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 106697
• Device Lot Number: 18F0501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2019
• Distributor Facility Aware Date: 01/21/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/14/2019
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1