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); Syncope/Fainting (4411)

Event Date 10/21/2021

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 of a syncopal episode associated with hypotension with subsequent admission to the icu for monitoring.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 an unknown date, this patient went to the hemodialysis clinic for an additional treatment after experiencing an adverse reaction the previous day (c-1038799) during dialysis in which the treatment was transitioned to ultrafiltration (uf) only.The patient was initiated on the treatment and noted to have a syncopal episode associated with hypotension (90/59 mmhg).This occurred shortly after treatment began.Blood glucose, arterial gas, and electrolytes were checked and all were within normal limits.Additionally, an ekg did not show any signs of acute ischemia and a bedside echocardiogram showed no abnormalities.The patient was transferred to the intensive care unit (icu) for monitoring.No further information was provided.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).On an unknown date, this patient went to the hemodialysis clinic for an additional treatment after experiencing an adverse reaction the previous day (c-1038799) during dialysis in which the treatment was transitioned to ultrafiltration (uf) only.The patient was initiated on the treatment and noted to have a syncopal episode associated with hypotension (90/59 mmhg).This occurred shortly after treatment began.Blood glucose, arterial gas, and electrolytes were checked and all were within normal limits.Additionally, an ekg did not show any signs of acute ischemia and a bedside echocardiogram showed no abnormalities.The patient was transferred to the intensive care unit (icu) for monitoring.No further information was provided.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.

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).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.On (b)(6) 2021 this male hd patient presented to the hd clinic for an additional treatment after experiencing an adverse reaction the previous day (c-1038799).During that dialysis treatment, the patient was transitioned to ultrafiltration (uf) only.The patient¿s pre-treatment blood pressure was documented as 194/166 mmhg which is suspected to be incorrect as the patient was moving at the time it was obtained.The patient¿s treatment was initiated.Approximately 10-12 minutes into the treatment, the patient began to pass out.The patient¿s blood pressure was 90/59 mmhg at the time of the event.Arterial blood was reinfused, and the patient responded again.Dialysis was stopped.The dialysis unit is located within the hospital so the hospital transport along with the rn and md took the patient to the emergency room.Blood glucose, arterial gas, and electrolytes were checked and all were within normal limits.Additionally, an ekg did not show any signs of acute ischemia and a bedside echocardiogram showed no abnormalities.The patient was transferred to the intensive care unit (icu) for monitoring.No further information was provided.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.

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).Additional information was provided on (b)(6) 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.On (b)(6) 2021 this male hd patient presented to the hd clinic for an additional treatment after experiencing an adverse reaction the previous day (c-1038799).During that dialysis treatment, the patient was transitioned to ultrafiltration (uf) only.The patient¿s pre-treatment blood pressure was documented as 194/166 mmhg which is suspected to be incorrect as the patient was moving at the time it was obtained.The patient¿s treatment was initiated.Approximately 10-12 minutes into the treatment, the patient began to pass out.The patient¿s blood pressure was 90/59 mmhg at the time of the event.Arterial blood was reinfused, and the patient responded again.Dialysis was stopped.The dialysis unit is located within the hospital so the hospital transport along with the rn and md took the patient to the emergency room.Blood glucose, arterial gas, and electrolytes were checked and all were within normal limits.Additionally, an ekg did not show any signs of acute ischemia and a bedside echocardiogram showed no abnormalities.The patient was transferred to the intensive care unit (icu) for monitoring.No further information was provided.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

Additional information: b5.

• 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: 16361811
• MDR Text Key: 309371763
• Report Number: 0008030665-2023-00148
• 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,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 03/02/2023; 03/29/2023; 04/11/2023
• Supplement Dates FDA Received: 03/02/2023; 04/11/2023; 04/17/2023
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male