MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number UNKNOWN- FMC BLOODLINE

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Syncope/Fainting (4411)

Event Date 10/21/2021

Event Type  Injury  

Event Description

On (b)(6) 2023, fresenius was made aware of an article, ¿anaphylaxis from ethylene oxide¿sterilized dialysis tubing and needles: a case report.¿ in the article, there is documentation of a 78-year-old male hemodialysis (hd) patient experiencing an adverse event during treatment utilizing the fresenius combiset tubing.The patient has been completing hd for approximately 2.5 years without significant complications.The patient was previously on peritoneal dialysis.The patient had recently been utilizing a tunneled dialysis catheter (tdc) and transitioned back to use of a right upper extremity arteriovenous fistula (avf).On an unknown date, this patient went to the hemodialysis clinic for an additional treatment after experiencing an adverse reaction the previous day (b)(6) during dialysis in which the treatment was transitioned to ultrafiltration (uf) only.The patient was initiated on the treatment and noted to have a syncopal episode associated with hypotension (90/59 mmhg).This occurred shortly after treatment began.Blood glucose, arterial gas, and electrolytes were checked and all were within normal limits.Additionally, an ekg did not show any signs of acute ischemia and a bedside echocardiogram showed no abnormalities.The patient was transferred to the intensive care unit (icu) for monitoring.No further information was provided.The patient eventually underwent labwork in which the findings showed eosinophilia and mast cell degranulation.Additionally, the patient was treated with various medications including cetirizine, prednisone, famotidine, and diphenhydramine.These medications along with rinsing of the circuit twice with normal saline eventually permitted the patient to endure the hd treatment without an adverse reaction.

Event Description

On 25/jan/2023, fresenius was made aware of an article, ¿anaphylaxis from ethylene oxide¿sterilized dialysis tubing and needles: a case report.¿ in the article, there is documentation of a 78-year-old male hemodialysis (hd) patient experiencing an adverse event during treatment utilizing the fresenius combiset tubing.The patient has been completing hd for approximately 2.5 years without significant complications.The patient was previously on peritoneal dialysis.The patient had recently been utilizing a tunneled dialysis catheter (tdc) and transitioned back to use of a right upper extremity arteriovenous fistula (avf).Additional information was provided on 29/mar/2023 through follow-up with the co-author of the article.This clinical investigation includes that information and the information obtained through the initial article.On 21/oct/2021 this male hd patient presented to the hd clinic for an additional treatment after experiencing an adverse reaction the previous day (b)(6).During that dialysis treatment, the patient was transitioned to ultrafiltration (uf) only.The patient¿s pre-treatment blood pressure was documented as 194/166 mmhg which is suspected to be incorrect as the patient was moving at the time it was obtained.The patient¿s treatment was initiated.Approximately 10-12 minutes into the treatment, the patient began to pass out.The patient¿s blood pressure was 90/59 mmhg at the time of the event.Arterial blood was reinfused, and the patient responded again.Dialysis was stopped.The dialysis unit is located within the hospital so the hospital transport along with the rn and md took the patient to the emergency room.Blood glucose, arterial gas, and electrolytes were checked and all were within normal limits.Additionally, an ekg did not show any signs of acute ischemia and a bedside echocardiogram showed no abnormalities.The patient was transferred to the intensive care unit (icu) for monitoring.No further information was provided.The patient eventually underwent labwork in which the findings showed eosinophilia and mast cell degranulation.Additionally, the patient was treated with various medications including cetirizine, prednisone, famotidine, and diphenhydramine.These medications along with rinsing of the circuit twice with normal saline eventually permitted the patient to endure the hd treatment without an adverse reaction.

Event Description

On 25/jan/2023, fresenius was made aware of an article, ¿anaphylaxis from ethylene oxide¿sterilized dialysis tubing and needles: a case report.¿ in the article, there is documentation of a 78-year-old male hemodialysis (hd) patient experiencing an adverse event during treatment utilizing the fresenius combiset tubing.The patient has been completing hd for approximately 2.5 years without significant complications.The patient was previously on peritoneal dialysis.The patient had recently been utilizing a tunneled dialysis catheter (tdc) and transitioned back to use of a right upper extremity arteriovenous fistula (avf).Additional information was provided on 29/mar/2023 through follow-up with the co-author of the article.This clinical investigation includes that information and the information obtained through the initial article.On 21/oct/2021 this male hd patient presented to the hd clinic for an additional treatment after experiencing an adverse reaction the previous day (c-1038799).During that dialysis treatment, the patient was transitioned to ultrafiltration (uf) only.The patient¿s pre-treatment blood pressure was documented as 194/166 mmhg which is suspected to be incorrect as the patient was moving at the time it was obtained.The patient¿s treatment was initiated.Approximately 10-12 minutes into the treatment, the patient began to pass out.The patient¿s blood pressure was 90/59 mmhg at the time of the event.Arterial blood was reinfused, and the patient responded again.Dialysis was stopped.The dialysis unit is located within the hospital so the hospital transport along with the rn and md took the patient to the emergency room.Blood glucose, arterial gas, and electrolytes were checked and all were within normal limits.Additionally, an ekg did not show any signs of acute ischemia and a bedside echocardiogram showed no abnormalities.The patient was transferred to the intensive care unit (icu) for monitoring.No further information was provided.The patient eventually underwent labwork in which the findings showed eosinophilia and mast cell degranulation.Additionally, the patient was treated with various medications including cetirizine, prednisone, famotidine, and diphenhydramine.These medications along with rinsing of the circuit twice with normal saline eventually permitted the patient to endure the hd treatment without an adverse reaction.

• Brand Name: FMC BLOODLINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 16440448
• MDR Text Key: 310225421
• Report Number: 3023981687-2023-00042
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2023,04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN- FMC BLOODLINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2023
• Distributor Facility Aware Date: 01/25/2023
• Device Age: MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Date Manufacturer Received: 04/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male