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 Itching Sensation (1943); Rash (2033)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A search for the lots of the orders of bloodline products shipped to the user facility in the last 3 months was performed, however, there was no record of any these products being shipped to the user facility.A manufacturing review of device history records (dhr) could not be completed because a lot was unavailable.As a physical evaluation or dhr review could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

Event Description

It was reported that a patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt), received preventative medical intervention with intravenous (iv) benadryl 50 mg prior to initiating hemodialysis (hd) due to the patient's history of allergic reactions to ethylene oxide gas used to sterilize the combiset.The patient had previously experience rash and itching on non-fresenius hd blood line products in the past.The reactions were attributed to the ethylene oxide gas used to sterilize the blood lines.The patient was dialyzing in-center on a fresenius 2008t hemodialysis machine.The patient is pre-medicated with iv benadryl 50 mg, 30 minutes prior to each treatment (unknown number of treatments).The patient is currently being treated with a nipro elisio 17h dialyzer (rinsed with 2.0 liters of normal saline pretreatment), in combination with a fresenius combiset bloodline (rinsed with 6.0 liters of normal saline pretreatment).The patient is reportedly tolerating the treatments but plans on returning to peritoneal dialysis (pd) therapy when able.The plan is to transition the patient back to pd therapy on approximately (b)(6) 2020, utilizing a baxter cycler and supplies.Additional information was requested (e.G.Discharge summaries, treatment records), however these documents were unavailable during the call.

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the fresenius combiset bloodlines and the serious adverse events of hypersensitivity/allergic reaction, itching and rash, which requires the pre-treatment administration of benadryl.The definitive etiology of the events is unknown; therefore, causality cannot be firmly established.The patient is utilizing a non-fresenius dialyzer in conjunction with the fresenius combiset bloodlines.However, given the patient¿s itching/rash during treatment was remediated utilizing benadryl prior to treatment, a possible causal or contributory role cannot be excluded.Based on the information available, the fresenius combiset bloodlines cannot be disassociated from the events.While uncommon, hypersensitivity reactions are known to occur with the use of optiflux dialyzers and/or other elements in the extracorporeal circuit.

• 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: 10151363
• MDR Text Key: 195161886
• Report Number: 8030665-2020-00798
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2020
• 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
• Device Age: MO
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR