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 Anaphylactic Shock (1703); Hypersensitivity/Allergic reaction (1907); Anaphylactoid (2218)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a possible causal association between use of the fmc blood line and/ or the fresenius optiflux dialyzer and the patient¿s (pt) reaction (unknown signs and symptoms).However, it cannot be determined what exactly caused the pt¿s reaction.Although rare, it is known that hypersensitivity or anaphylactoid reactions to optiflux dialyzers and other element in the extracorporeal circuit (including fmc blood lines) can occur during hemodialysis.Should additional information become available, this clinical investigation will be updated accordingly.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility reported that a hemodialysis (hd) patient was hospitalized due to the patient experiencing a reaction (unknown signs/symptoms) to the ethanol (etoh) sterilant used in the fmc combi-set bloodline.The reporter indicated that the patient was also using a fresenius optiflux dialyzer during the event.Upon follow up with the biomedical technician and the clinical manager (cm) it was stated that the patient could not tolerate being dialyzed with fresenius bloodlines and optiflux dialyzer; therefore, the patient was switched to nxstage for hd therapy.The cause of the patient reaction was unknown.Additionally, it was stated that the patient has since moved to another clinic.Additional information regarding patient¿s demographics, status/outcome and medical records and clinic information were requested; however, to date none has been received.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A search for potential lot number delivered to the patient was performed resulting in six different lot numbers.An investigation of the device history records (dhr) was conducted by the manufacturer of potential related lots.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lots have been sold and distributed.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

On (b)(6) 2018, this 34-year-old patient (pt.) with a past medical history significant for end stage renal disease (esrd) on hemodialysis (hd) (for years), diabetes mellitus, hypertension, morbid obesity and charcot arthropathy of the left ankle presented to the hospital with hyperkalemia (7.3), fluid volume overload (198 kg on admission), severe metabolic acidosis and hypoxic/hypercarbic respiratory failure in the setting of missing one week of hd treatment for unknown reason.In the emergency room (er), on the patient resumed hd treatment while inpatient and within minutes of blood return upon initiation of hd treatment via unknown dialysis machine using fmc combi-set bloodline and optiflux f200nr dialyzer, the patient.Developed headache, shortness of breath (sob), respiratory distress with white foamy sputum and hypotension (blood pressure (bp) recorded 50/30) with altered mental status (ams).The patient was intubated (due to hypoxic respiratory failure) and blood pressure managed with vasopressor support and patient was subsequently switched to continuous venovenous hemofiltration with a next stage car-505 dialyzer overnight.The patient was able to be extubated the next day and hd treatment was attempted again using the optiflux f200nr dialyzer.Within five minutes, the patient felt hot with projectile vomiting and became hypotensive (bp 70/40).Subsequently on (b)(6) 2018, hd was trialed again with a switch to an exeltra-170 dialyzer and again within minutes of start of hd treatment, the patient became hot, restless and hypotensive (unknown bp).At this time, there was suspicion for a hd catheter infection and as a result the patient underwent hd catheter exchange on (b)(6) 2018.During hospitalization, the patient was on deep vein thrombosis (dvt) prophylaxis with subcutaneous and intravenous (iv) heparin.On (b)(6) 2018, the patient underwent previously scheduled left below the knee amputation (bka) for chronic infection of left ankle and on the same day it was discovered the patient¿s hd catheter (not a fresenius product) was clotted.On (b)(6) 2018, the hd catheter was replaced.It was recorded the patient¿s continuous renal replacement therapy (crrt)/hd was held during this time.On (b)(6) 2018, the patient was reattempted on hd therapy using exeltra dialyzer and within five minutes of hd start the patient developed sob and hypotensive (bp recorded in 60¿s) warranting resuscitation with epipen, 125 milligrams (mg) solumedrol, 20 mg pepcid, 50 mg benadryl, norepinephrine drip (gtt), vasopressin and epinephrine.On (b)(6) 2018, the patient was consulted by allergy/immunology where it was recorded that the patient¿s symptoms of hypotension, of tongue and chest tightness shortly after initiation of hd is consistent with anaphylaxis.The exact cause for the patient¿s sensitivity could not be identified due to multiple possible triggers including different dialyzer membranes and dialysate contents used, possible sterilant exposure with ethylene oxide, underlying pork related allergy from heparin iv drip, mammalian meat allergy, and/or possible latex allergy with unknown latex exposure.Further immunology testing for specific antigens (specifically ige to alpha gal, latex and pork).After the four reaction events, the patient was switched to nxstage machine and streamline express dialyzer/ blood tubing and able to tolerate further hd treatment in the hospital without issue.The patient was discharged (b)(6) 2018 continuing on hd therapy with nxstage/streamline express dialysis products.

Manufacturer Narrative

Correction: occupation.Additional information: patient codes, medial records.Clinical investigation: based on the available information, the patient¿s hyperkalemia, fluid volume overload, metabolic acidosis and respiratory failure which initially led to hospitalization was related to missing one week of hd therapy (unknown reason).Additionally, it cannot be determined what exactly caused the patient¿s anaphylactic reactions within minutes of initiating hd treatment four times while hospitalized.There is a temporal association between use of the fmc blood line and/ or the fresenius optiflux dialyzer on and the patient¿s anaphylactic reaction characterized by hypoxic respiratory failure with significant hypotension, chest tightness and projectile vomiting.Although rare, it is known that hypersensitivity or anaphylactoid reactions to optiflux dialyzers and other element in the extracorporeal circuit (including fmc blood lines) can occur during hemodialysis.However, after initial anaphylactic reactions with concomitant use of fresenius products, the patient was switched to the exeltra dialyzer, and the patient¿s anaphylactic symptoms persisted.Other suspected allergen triggers included possible sterilant exposure with ethylene oxide, underlying pork related allergy from concomitant use of heparin iv, mammalian meat allergy, and/or possible latex allergy with unknown latex exposure.Further immunology testing to confirming sensitivity is unknown.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 7510426
• MDR Text Key: 108116350
• Report Number: 8030665-2018-00689
• 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: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- FMC BLOODLINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 174