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  

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 adverse reaction classified by hypotension, itching, cramping, and a sensation of his throat closing.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.(lara & martín-malo, 2014) 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).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 trialed 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.

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 trialed 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.

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 review was not performed since the lot number is unknown and no information was found on the 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.There is no allegation or objective evidence indicating a fresenius product(s) or device(s) deficiency or malfunction occurred.Based on the information available in the complaint file, a causal relationship between the product and the incident cannot be determined.

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).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 trialed 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.

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 review was not performed since the lot number is unknown and no information was found on the 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.There is no allegation or objective evidence indicating a fresenius product(s) or device(s) deficiency or malfunction occurred.Based on the information available in the complaint file, a causal relationship between the product and the incident cannot be determined.

• 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: 16359724
• MDR Text Key: 309370935
• Report Number: 0008030665-2023-00146
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2023
• 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
• Device Age: MO
• Date Manufacturer Received: 03/05/2023
• 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): Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic