MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 14L DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109651

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

Patient Problems Dyspnea (1816); Chest Tightness/Pressure (2463)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6). Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that five minutes into treatment with a polyflux 14l, a patient experienced cough, chest tightness and shortness of breath. The treatment was discontinued and blood was returned to the patient. The patient was immediately treated with dexamethasone injection 5mg intravenously and was placed on continuous low flow oxygen. It was reported that symptoms persisted and the patient was treated with an intravenous injection of dexamethasone 10mg, 0. 9% sodium chloride injection 20ml and 10% calcium gluconate injection 20ml and was closely monitored. At the time of the report, the patient outcome was not reported. No additional information is available.

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.

• Brand Name: POLYFLUX 14L
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 7861981
• MDR Text Key: 119795528
• Report Number: 9611369-2018-00097
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K043342
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 109651
• Device Lot Number: 7-5007-H-01
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 09/10/2018 Patient Sequence Number: 1