MAUDE Adverse Event Report: ST. WENDEL AG FX CORAL FX80 HF 24/CS 1.8SA STEAM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number F00009217

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Syncope/Fainting (4411)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

On (b)(6) 2024, fresenius became aware of this hemodialysis (hd) patient on in center hd therapy utilizing the fx coral 80 dialyzer who experienced a dialyzer reaction during an hd treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon review of the information provided in the intake and follow up with the country complaint administrator, it was reported this patient experienced severe hypotension and loss of consciousness during an hd treatment on (b)(6) 2023.It was stated by the clinic medical director that this patient was initially presented to the clinic from a community hospital following a diagnosis of allergy to polysulfone membranes of dialyzers (brand and model unknown) prior to this event.The patient showed significance in his sensitivity to dialyzers with the initial utilization of the coral line of dialyzers as he initially presented with mild hypotension (requiring a one-time bolus of fluids and discontinuation of ultrafiltration) and three syncopal episodes with previous treatments.For the event that occurred on (b)(6) 2023, the patient presented with dyspnea and a more severe hypotension than previous occurrences that more than likely directly attributed to the loss of consciousness.Medical interventions included an intravenous bolus of saline and administration of both steroidal and antihistamine medications (types and dosages not reported).The patient was able to continue the hd treatment on a competitor dialyzer on the same day without incident.The patient continues hd therapy following these events with the competitor dialyzer with no further reported adverse events.

Event Description

On 10/jan/2024, fresenius became aware of this hemodialysis (hd) patient on in-center hd therapy utilizing the fx coral 80 dialyzer who experienced a dialyzer reaction during an hd treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon review of the information provided in the intake and follow up with the country complaint administrator, it was reported this patient experienced severe hypotension and loss of consciousness during an hd treatment on (b)(6) 2023.It was stated by the clinic medical director that this patient was initially presented to the clinic from a community hospital following a diagnosis of allergy to polysulfone membranes of dialyzers (brand and model unknown) prior to this event.The patient showed significance in his sensitivity to dialyzers with the initial utilization of the coral line of dialyzers as he initially presented with mild hypotension (requiring a one-time bolus of fluids and discontinuation of ultrafiltration) and three syncopal episodes with previous treatments.For the event that occurred on (b)(6) 2023, the patient presented with dyspnea and a more severe hypotension than previous occurrences that more than likely directly attributed to the loss of consciousness.Medical interventions included an intravenous bolus of saline and administration of both steroidal and antihistamine medications (types and dosages not reported).The patient was able to continue the hd treatment on a competitor dialyzer on the same day without incident.The patient continues hd therapy following these events with the competitor dialyzer with no further reported adverse events.

Manufacturer Narrative

Correction provided in h1.Investigation: the reported event is adequately addressed in instructions for use and/or on the label and the and the product deficiency is not related to falsification.The sample is not available.Due to 100% testing, it is highly unlikely to detect a failure in the retention sample.Furthermore, only a small number of reserved samples are available.Therefore, the retention sample analysis is not complete.The cause for the reported failure cannot be confirmed based on the current available information.Device history review (dhr) revealed that the inspected products were found conforming to specifications.No indication for any relationship with the reported failure mode has been found during the review.Especially, the rinsing and sterilization parameters have been checked and no deviation from specification were found.No further complaints were found during complaint history review.The reported event is covered in the risk analysis.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

On 10/jan/2024, fresenius became aware of this hemodialysis (hd) patient on in-center hd therapy utilizing the fx coral 80 dialyzer who experienced a dialyzer reaction during an hd treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon review of the information provided in the intake and follow up with the country complaint administrator, it was reported this patient experienced severe hypotension and loss of consciousness during an hd treatment on (b)(6) 2023.It was stated by the clinic medical director that this patient was initially presented to the clinic from a community hospital following a diagnosis of allergy to polysulfone membranes of dialyzers (brand and model unknown) prior to this event.The patient showed significance in his sensitivity to dialyzers with the initial utilization of the coral line of dialyzers as he initially presented with mild hypotension (requiring a one-time bolus of fluids and discontinuation of ultrafiltration) and three syncopal episodes with previous treatments.For the event that occurred on 18/dec/2023, the patient presented with dyspnea and a more severe hypotension than previous occurrences that more than likely directly attributed to the loss of consciousness.Medical interventions included an intravenous bolus of saline and administration of both steroidal and antihistamine medications (types and dosages not reported).The patient was able to continue the hd treatment on a competitor dialyzer on the same day without incident.The patient continues hd therapy following these events with the competitor dialyzer with no further reported adverse events.

Manufacturer Narrative

Correction provided in h10.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: a temporal relationship exists between the utilization of the fx coral 80 dialyzer and the event of a hypersensitivity reaction to a dialyzer, characterized by dyspnea, syncopal episodes and mild to severe hypotension leading to a loss of consciousness.It is well documented that patients on any modality of hemodialysis may experience reactions involving non-biocompatibility due to the composition of membranes of various types of dialyzers.The cause of this adverse event can be attributed to this patient¿s intrinsic physiological response to dialyzer use with no indication of an unintended performance of any fresenius product(s) or device(s).This was evidenced by the patient¿s similar reactions on various types of dialyzers prior to this event and the decision to continue with the hd treatment on 18/dec/2023 with a more biocompatible competitor dialyzer.It also can be concluded the patient did not experience a serious injury as a result of this event as they were able to safely continue with hd therapy immediately following hypersensitivity mitigation.It can be concluded this event was not caused by a deficiency or malfunction of the fx coral 80 dialyzer.Based on the available information, there was no allegation or objective evidence of any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse events.

Event Description

On 10/jan/2024, fresenius became aware of this hemodialysis (hd) patient on in-center hd therapy utilizing the fx coral 80 dialyzer who experienced a dialyzer reaction during an hd treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon review of the information provided in the intake and follow up with the country complaint administrator, it was reported this patient experienced severe hypotension and loss of consciousness during an hd treatment on (b)(6) 2023.It was stated by the clinic medical director that this patient was initially presented to the clinic from a community hospital following a diagnosis of allergy to polysulfone membranes of dialyzers (brand and model unknown) prior to this event.The patient showed significance in his sensitivity to dialyzers with the initial utilization of the coral line of dialyzers as he initially presented with mild hypotension (requiring a one-time bolus of fluids and discontinuation of ultrafiltration) and three syncopal episodes with previous treatments.For the event that occurred on 18/dec/2023, the patient presented with dyspnea and a more severe hypotension than previous occurrences that more than likely directly attributed to the loss of consciousness.Medical interventions included an intravenous bolus of saline and administration of both steroidal and antihistamine medications (types and dosages not reported).The patient was able to continue the hd treatment on a competitor dialyzer on the same day without incident.The patient continues hd therapy following these events with the competitor dialyzer with no further reported adverse events.

Event Description

On (b)(6) 2024, fresenius became aware of this hemodialysis (hd) patient on in-center hd therapy utilizing the fx coral 80 dialyzer who experienced a dialyzer reaction during an hd treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon review of the information provided in the intake and follow up with the country complaint administrator, it was reported this patient experienced severe hypotension and loss of consciousness during an hd treatment on (b)(6) 2023.It was stated by the clinic medical director that this patient was initially presented to the clinic from a community hospital following a diagnosis of allergy to polysulfone membranes of dialyzers (brand and model unknown) prior to this event.The patient showed significance in his sensitivity to dialyzers with the initial utilization of the coral line of dialyzers as he initially presented with mild hypotension (requiring a one-time bolus of fluids and discontinuation of ultrafiltration) and three syncopal episodes with previous treatments.For the event that occurred on (b)(6) 2023, the patient presented with dyspnea and a more severe hypotension than previous occurrences that more than likely directly attributed to the loss of consciousness.Medical interventions included an intravenous bolus of saline and administration of both steroidal and antihistamine medications (types and dosages not reported).The patient was able to continue the hd treatment on a competitor dialyzer on the same day without incident.The patient continues hd therapy following these events with the competitor dialyzer with no further reported adverse events.

• Brand Name: FX CORAL FX80 HF 24/CS 1.8SA STEAM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ST. WENDEL AG; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): ST. WENDEL AG; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18581591
• MDR Text Key: 334758601
• Report Number: 3002807005-2024-00002
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K220721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/19/2024

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 Catalogue Number: F00009217
• Device Lot Number: E8FB09100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 02/02/2024; 02/07/2024; 02/09/2024; 02/09/2024
• Supplement Dates FDA Received: 02/06/2024; 02/07/2024; 02/09/2024; 02/19/2024
• 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: Initial
• Patient Sequence Number: 1
• Treatment: AV-SET 5008 CORDIAX POST R; AV-SET 5008 CORDIAX POST R; AV-SET 5008 CORDIAX POST R; AV-SET 5008 CORDIAX POST R; DIAMIX AC-F313; DIAMIX AC-F313; DIAMIX AC-F313; DIAMIX AC-F313
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 85 KG