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

Catalog Number 107142

Device Problem Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

The four samples have been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the effluent line (yellow) was mismatched with the pre blood line (white) line on four (4) prismaflex hf1400 sets.This was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Four (4) samples were received for investigation.Sample analysis revealed that all samples had an incorrect assembly of the effluent and pbp lines, the lines are reversed.One (1) sample was tested via simulated conditions on a prismaflex machine.Aside from the reversed lines, no visual anomalies were detected.No leak and no air intake were detected during the priming test, and during the final self test, no alarm was triggered.The reported condition was verified for all four returned samples.The cause of the condition was determined to be a manufacturing issue.The involved operator was retrained and awareness training has provided to all operators.The batch involved in this report was manufactured prior to these actions.Should additional relevant information become available, a supplemental report will be submitted.

• 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
• 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: 7385205
• MDR Text Key: 104161606
• Report Number: 8010182-2018-00022
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414069315
• UDI-Public: (01)07332414069315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/30/2018,05/04/2018

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: 09/01/2019
• Device Catalogue Number: 107142
• Device Lot Number: 17I0704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2018
• Distributor Facility Aware Date: 03/02/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/30/2018
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 04/13/2018
• Supplement Dates FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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