MAUDE Adverse Event Report: BAXTER HEALTHCARE - OPELIKA REVACLEAR 300; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114745L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Dyspnea (1816); Seizures (2063)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that within 2-3 minutes after starting treatment with a revaclear dialyzer, the patient experienced a cardiac episode, seizure like activity, unresponsiveness, pulseless, agonal breathing and the patient¿s face turned blue/purple.Treatment was discontinued.It was reported a code was called and cardiopulmonary resuscitation (cpr) was initiated.A swishing sound was heard during heart auscultation and was advised not to shock via aed device.Oxygen 8l was provided.The patient recovered consciousness and normal breathing resumed.The cause of the events was unknown.It was reported the event started as soon as the blood had passed through the extracorporeal circuit.The extracorporeal blood was not returned to the patient.It was reported the total blood loss was 100 ml.The patient was admitted to hospital for ¿a couple of days with a cardiac workup¿.It was reported the patient received another treatment the same day after hospital admission.At the time of this report, the patient outcome was not reported.No additional information is available.

• Brand Name: REVACLEAR 300
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - OPELIKA; opelika AL
• 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: 8511395
• MDR Text Key: 141912443
• Report Number: 3006552611-2019-00014
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123055
• UDI-Public: (01)07332414123055
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130039
• 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
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2021
• Device Catalogue Number: 114745L
• Device Lot Number: C418133801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/12/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR