MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114749M

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter first name: e1: initial reporter last name: e1: initial reporter facility name: should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a foreign object similar to eyelashes was found in a revaclear 400 apac.This was identified during priming for hemodialysis treatment.The tubing set and dialyzer were replaced.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H11: the device was received for evaluation.Visual inspection was performed and a brownish hair-like particle was found that was partially moulded into pur (polyurethane).On the location of the hair-like particle was also identified an organic stain (film) with several small particles.The reported condition was verified.The cause of the condition was manufacturing related.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: REVACLEAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - OPELIKA; 1101 jeter ave; opelika AL 36801
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19015017
• MDR Text Key: 339094049
• Report Number: 3006552611-2024-00010
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414126186
• UDI-Public: (01)07332414126186
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 04/01/2024

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 Catalogue Number: 114749M
• Device Lot Number: C423206701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2024
• Initial Date FDA Received: 04/01/2024
• Date Device Manufactured: 03/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1