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 Low Blood Pressure/ Hypotension (1914); Nausea (1970); Dizziness (2194)

Event Date 10/20/2021

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 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 a routine hd treatment (date not provided), this patient experienced hypotension with presyncopal symptoms (unspecified) shortly after initiation of dialysis.The patient¿s blood pressure was 84/59 mmhg.The symptoms resolved with a bolus of normal saline (volume not provided).The treatment was transitioned to ultrafiltration only and the access was also changed back to tdc.The patient had a reaction on the previous hd therapy with hypotension and bradycardia.That event was attributed to the patient¿s anti-hypertensive medication.The patient had decreased the medication with stable blood pressure results.The article continues to cover additional adverse events during hd treatments.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.

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.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 presyncopal symptoms (unspecified).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.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.

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).On a routine hd treatment (date not provided), this patient experienced hypotension with presyncopal symptoms (unspecified) shortly after initiation of dialysis.The patient¿s blood pressure was 84/59 mmhg.The symptoms resolved with a bolus of normal saline (volume not provided).The treatment was transitioned to ultrafiltration only and the access was also changed back to tdc.The patient had a reaction on the previous hd therapy with hypotension and bradycardia.That event was attributed to the patient¿s anti-hypertensive medication.The patient had decreased the medication with stable blood pressure results.The article continues to cover additional adverse events during hd treatments.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.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.No shipping search could be performed for the lots delivered to the facility since there is no facility number reported or additional information for the search.Consequently no product will be returned from the distribution center to be analyzed since the lot number is unknown and no information from the facility is available for the identified of the possible involved lots.Since the complaint sample is not available for evaluation neither photos or videos were provided for evaluation and a device history report review was not performed since the lot number is unknown and no information was found on the sap system, the alleged event could not be confirmed.At this time, no sample has been provided.Should the sample become available, the investigation file will be reopened and will be updated accordingly.

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.This male hemodialysis patient was in treatment on (b)(6) 2021.Twelve minutes into the treatment, the patient experienced light-headedness, dizziness, and nausea.The patient¿s blood pressure was 84/59 mmhg.The patient was administered a 200ml bolus of normal saline (ns).This was considered medical intervention.The patient¿s dialysis access was changed for the remainder of this treatment from the avf to the tdc.The treatment was transitioned to ultrafiltration only.The symptoms resolved with the bolus of ns.It was realized at the time that this patient had been taking the incorrect dosage of nifedipine.The patient was prescribed 60mg every morning and 90mg at bedtime.The patient had run out of the 30mg pills.The patient had been taking one 60mg pill and one half of the 60mg tab in the evening to account for the 90mg.It was explained to the patient that nifedipine should not be cut in half.A new prescription was issued for the patient to pick up.The patient was asked to take only 60mg nifedipine (in place of the 90mg) that evening if his blood pressure allowed.The patient had a reaction on the previous hd treatment on (b)(6) 2021 with hypotension and bradycardia.That event was attributed to the patient¿s anti-hypertensive medication, metoprolol.The patient had decreased the medication with stable blood pressure results.The article continues to cover additional adverse events during hd treatments.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 prior to each treatment, eventually permitted the patient to endure the hd treatment without an adverse reaction.

Manufacturer Narrative

Additional information: b3 date of event, b5, health effect - clinical code, h10 clinical investigation 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 presyncopal symptoms of light-headedness, dizziness, and nausea.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.Although it was not determined at the time of the event, 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.Should additional information become available, the need for a clinical investigation will be reassessed.

• 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: 16361869
• MDR Text Key: 309372971
• Report Number: 0008030665-2023-00149
• 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,Followup,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• 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