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 Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144); Tingling (2171); Dizziness (2194); Malaise (2359); Palpitations (2467); Abdominal Distention (2601)

Event Date 01/30/2019

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 10 minutes into treatment with a polyflux 170h dialyzer, a hemodialysis patient experienced a tingling sensation, body unwell, difficulty breathing, hoarse voice, abdominal distension, nausea, vomiting (twice), dizziness and low blood pressure (90/60 mmhg).It was reported the blood was returned and treatment was discontinued.A 50% glucose injection, 60 ml intravenous injection and infusion of 0.9% saline water 500ml was administered without improvement.It was reported an allergic reaction was suspected and dexamethasone 10 mg intravenous injection and adrenaline 1 mg subcutaneous injection were administrated.Two minutes later, the patient felt better, reported as ¿smooth breathing, voice recover, still felt dizzy¿, blood pressure was110/70mmhg.Five minutes later the patient experienced palpitations and an unspecified 60 mg intravenous injection and dopamine 200 mg intravenous infusion were administered.It was reported the ¿palpitations calmed down¿ after the adrenaline 1 mg; ¿however, patient experienced obvious dizziness and lack of movement¿.Blood pressure was reported as 100/60 mmhg with dopamine.Subsequently, the patient was admitted to the intensive care unit.The patient was discharged five days after hospital admission.At the time of this report, the patient outcome was not reported.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 ; 2242702068
• MDR Report Key: 8418737
• MDR Text Key: 138753169
• Report Number: 9611369-2019-00027
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/13/2019

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: 07/31/2021
• Device Catalogue Number: 112466
• Device Lot Number: 8-4918-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 03/13/2019
• 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: 23 YR