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 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 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.

Manufacturer Narrative

Plant investigation: since the lot number is unknown and the facility number is unknown could not be performed a sap shipping search for the possible involved lots.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Clinical investigation: based on the available information, there is a temporal and a likely causal relationship between the fresenius combiset tubing and the patient¿s reaction of hypotension and bradycardia requiring the administration of oxygen.Although rare, hypersensitivity or anaphylactoid reactions to dialysis equipment sterilized with ethylene oxide (eto) are a known risk during hemodialysis.The reactions that occur during hd are the result of an immunoallergic response by the patient after exposure to foreign substances present in the extracorporeal circuit.At the time of the event, it was suspected that the patient¿s anti-hypertensive medication could possibly be the cause of the hypotension and bradycardia.However, it was later concluded that the patient¿s resumption of his avf access exposed him to additional products sterilized with eto in the needles (not a fresenius product) used for the hd treatments.The use of the needles in conjunction with the combiset tubing triggered a memory immune response in the patient leading to mast cell degranulation and repeated anaphylactic episodes.This was supported by the consistent timing of the episodes immediately after initiation of hemodialysis with gradual worsening in severity.The immediate and positive response to steroid pe-treatment further supported the theory that these events were allergic in nature.There is no evidence of a fresenius combiset tubing product deficiency or malfunction.Additionally, although the patient experienced an adverse reaction during treatment, there is no allegation of a product malfunction or deficiency related to this event.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16786350
• MDR Text Key: 313735873
• Report Number: 0008030665-2023-00381
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• 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
• Device Age: MO
• Date Manufacturer Received: 03/29/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male