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 Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 10/18/2021

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 had 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).Initial information within the article outlined that this patient experienced hypotension and bradycardia during an hd treatment.The symptoms resolved when treatment was discontinued.The patient was instructed to decrease his anti-hypertensive medications.No further information was provided in the article.Additional information was provided through follow-up with the co-author of the article.The patient was in an hd treatment on (b)(6) 2021.Approximately 15 minutes into a three-hour treatment, the patient¿s oxygen (o2) desaturated to 89% on room air.Additionally, the patient¿s blood pressure (bp) was 96/52 mmhg, heart rate (hr) 53, and respiration rate (rr) 18.The patient was administered medical intervention with 6l o2 via nasal canula (nc) which brought his o2 saturation to 96%.Repeat vitals were taken by the rapid response team (dialysis unit is located within the hospital) with bp 122/68 mmhg, and o2 sat 96% after a reduction to 3l o2.The patient was able to complete the hd treatment.The patient was instructed to reduce his home metoprolol dose from 100mg two times a day (bid) to 50mg bid.No additional information was provided.

• 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: 16786360
• MDR Text Key: 313736251
• Report Number: 3023981687-2023-00083
• 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: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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: 04/21/2023
• Distributor Facility Aware Date: 03/29/2023
• Device Age: MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/21/2023
• Date Manufacturer Received: 03/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention