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); Anxiety (2328)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the product information was not provided.A search was performed on the products shipped to the facility for a three (3) month time frame immediately preceding the event occurrence date.The search results revealed that no combi set bloodlines were delivered during that time frame.Therefore, a manufacturing review could not be performed and neither could a device history records (dhr) review.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Clinical investigation: a temporal relationship exists between hd therapy utilizing the fresenius combi set bloodlines, optiflux 160nre dialyzer and the serious adverse events of dialyzer reaction, wheezing and anxiety, which required emergent discontinuation of hd therapy.The definitive etiology of the events is unknown; therefore, causality cannot be firmly established.However, given the patient¿s wheezing and anxiety during hd therapy, a possible causal or contributory role cannot be excluded.Based on the information available, the fresenius combi set bloodlines and/or optiflux 160nre dialyzer 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.Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.

Event Description

It was reported that a hemodialysis (hd) patient experienced a suspected allergic reaction (per the nephrologist) to the fresenius combi set bloodlines.Follow-up with the patient¿s inpatient dialysis program manager (idpm) revealed the patient was hospitalized on (b)(6) 2020 for hyperkalemia, acute kidney failure (due to cancer, specifics not provided) and dyspnea.On (b)(6) 2020, the patient underwent a temporary hemodialysis (hd) catheter (not a fresenius product) placement and was started on intermittent hd while being monitored by telemetry in the intensive care unit (icu).The patient was alert and oriented, and after hd was initiated on (b)(6) 2020, the patient began wheezing and feeling an overwhelming sense of anxiety or ¿impending doom.¿ initially it was felt the patient may be having a reaction to the fresenius combi set bloodlines, however further evaluation revealed the likely source of the allergic reaction to be caused by the sterilization methods of the optiflux 160nre dialyzer.The patient¿s treatment was discontinued; however no additional information was provided.The treatment record was requested; however, the request was declined.The combi set product information was not provided.

Manufacturer Narrative

Corrected information: a3 (inadvertently omitted), e1 (state inadvertently omitted), h6 (method code inadvertently omitted) additional information.

• 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: 10136410
• MDR Text Key: 194614455
• Report Number: 8030665-2020-00778
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• 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: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS OPTIFLUX 160NRE DIALYZER; FRESENIUS OPTIFLUX 160NRE DIALYZER
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR