MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER REVACLEAR 400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114746

Device Problem Leak/Splash (1354)

Patient Problems Fainting (1847); Laceration(s) (1946); Blood Loss (2597)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an external blood leak occurred during patient treatment with a revaclear 400.The dialyzer was found to have a loose arterial line at the header of the dialyzer.The reporter stated that the patient woke up and saw blood was leaking out on the dialyzer, they fainted and experienced a cut on their forehead resulting in an unspecified amount of blood loss.The patient went to the emergency room after the event and had the cut sutured.The patient was discharged from the emergency room on the same day and was reported to be doing 'fine".No additional information is available.

• Brand Name: REVACLEAR 400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• Manufacturer (Section G): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; holger - crafoord - strasse 26; hechingen D-723 79; GM D-72379
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7750727
• MDR Text Key: 116045433
• Report Number: 9611369-2018-00076
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 114746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 32 YR