MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 17L; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109650

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

Patient Problems Dyspnea (1816); Diaphoresis (2452)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.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 approximately 20 minutes after starting treatment with a polyflux 17l, the patient experienced chest tightness, shortness of breath, and sweating.Treatment was discontinued.The patient was treated with oxygen, 50% glucose water 20ml+ calcium gluconate 2g intravenous (iv) infusion and iv infusion of dexamethasone it was reported symptoms were relieved "about 10 minutes later." no additional information is available.

• Brand Name: POLYFLUX 17L
• 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 - HECHINGEN BADEN DIALYZER; holger - crafoord - strasse 26; hechingen D-723 79; GM D-72379
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12837111
• MDR Text Key: 284628471
• Report Number: 9611369-2021-00308
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414086626
• UDI-Public: (01)07332414086626
• 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
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 109650
• Device Lot Number: 1-4205-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• 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
• Patient Outcome(s): Required Intervention