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

Catalog Number 107142

Device Problems Disconnection (1171); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2019

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 during continuous renal replacement therapy treatment with a prismaflex hf1400 set, following exchange of the phoxilium replacement bag more than 24 hours into treatment, a ¿return disconnection¿ alarm was generated.There was no blood in the line.The deaeration chamber was reportedly ¿full of air¿ and the luer-lock screw of the purple line was defective (not further specified) and could not fix to the blue injection site of the phoxilium bag.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.The investigation of the return sample showed no crack or breakage was observed.The reported condition was not verified.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.

• Brand Name: PRISMAFLEX HF1400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu
• MDR Report Key: 8608966
• MDR Text Key: 145026846
• Report Number: 8010182-2019-00125
• Device Sequence Number: 1
• Product Code: KDI
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: 107142
• Device Lot Number: 18L0401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOL.PHOXILIUM (CODE: 113638); SOL.PHOXILIUM (CODE: 113638)