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); Itching Sensation (1943); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/01/2023

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).This patient was in the hospital being monitored in the intensive care unit (icu) for previous adverse reactions encountered during hemodialysis.On an unknown date, this patient was trailed on a low flow hd treatment.A baxter revaclear dialyzer was utilized in addition to the fresenius combiset.The circuit was primed twice with normal saline.Ten minutes into the hd treatment the patient complained of itching, cramping, and a sensation of his throat closing.The dialysis treatment was stopped after a systolic blood pressure (sbp) drop from 180s to 100s mmhg.No medical intervention was documented within the article.Allergy was then consulted on this patient¿s case.There were concerns for several causes of the patient¿s adverse reaction.However, idiopathic hypereosinophilic syndrome (hes), mastocytosis with eosinophilia, and mast cell activation syndrome (mcas) were ruled out.The patient had an elevated serum tryptase at 28 mcg/l (normal <11 mcg/l; concerning for anaphylaxis versus mcas), total ige (>3000 iu/ml), and very high level anti-eto ige antibody >100 ku/l (normal being <0.1 ku/l; concerning for anaphylaxis).Due to the concern for hypersensitivity to a component of the dialysis circuit, the patient was administered cetirizine 10 mg twice daily.The patient¿s next dialysis treatment was pre-treated with prednisone 1 mg/kg (80 mg), famotidine 20 mg and diphenhydramine 50 mg.The patient then tolerated a four-hour hd treatment utilizing the tdc with a revaclear dialyzer and tubing that had been primed and rinsed twice with normal saline.The patient then tolerated subsequent dialysis sessions utilizing the above regimen.Following discharge, the prednisone pre-treatment was tapered to 20 mg prior to dialysis.The patient was evaluated by allergy/immunology and received two doses of omalizumab.The plan was to eventually discontinue steroid pre-treatment.

• 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: 16440412
• MDR Text Key: 310228169
• Report Number: 3023981687-2023-00041
• 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
• Report Date: 02/24/2023

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: Health Professional
• 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: 01/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male