MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 170H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 112466

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

Patient Problems Dry Eye(s) (1814); Nausea (1970); Vomiting (2144); Abdominal Distention (2601)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).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.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.

Event Description

It was reported that a patient being treated with a polyflux 170h dialyzer became unwell 10 minutes into treatment and experienced ants like crawling sensation, difficulty breathing, abdominal distension, nausea and reported vomited twice.An allergic reaction was suspected and treatment was terminated.The patient was treated with 10 mg of dexamethasone intravenously and 1 mg subcutaneous adrenaline injection.After the dialyzing treatment was stopped, the polyflux 170h was replaced with another dialyzer and the patient recovered 10 minutes later.The four hours dialyzing treatment was successfully completed and the patient went home with no discomfort.No additional information is available.

• Brand Name: POLYFLUX 170H
• 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
• MDR Report Key: 8629027
• MDR Text Key: 145676997
• Report Number: 9611369-2019-00067
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414102760
• UDI-Public: (01)07332414102760
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K043342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2019

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: 08/31/2021
• Device Catalogue Number: 112466
• Device Lot Number: 8-4920-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/21/2019
• 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): Required Intervention