MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX HF1000; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 107140

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that air was noted to be entering into the access line from the pbp tubing 30 minutes into patient treatment with a prismaflex hf1000 set.No visible defect was noted and there were no issues during priming of the set.There was no patient injury or medical intervention associated with this event.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.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX HF1000
• 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: 7658821
• MDR Text Key: 113240639
• Report Number: 8010182-2018-00073
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414069254
• UDI-Public: (01)07332414069254
• 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: 07/03/2018,08/17/2018

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: 12/01/2019
• Device Catalogue Number: 107140
• Device Lot Number: 17L0703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2018
• Distributor Facility Aware Date: 06/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2018
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 07/23/2018
• Supplement Dates FDA Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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