MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- 2008T MACHINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.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.Should additional relevant information become available, a supplemental report will be submitted.  clinical investigation: a temporal relationship exists between an hd treatment using the 2008t hd machine and the event of an allergic reaction caused by a combination of iv venofer and iv mircera, characterized by facial flushing, restlessness, breathing difficulty and left lower back pain.It is well documented that patients on hemodialysis may experience reactions involving hypersensitivity to pharmacological agents that may trigger complement activation and increased bradykinin resulting from contact system activation.Intravenous iron is known to cause allergic reactions at an infrequent rate but with the potential to be life threatening.Based on the available information, there is no allegation or objective evidence indicating a fresenius device deficiency or malfunction, caused or contributed to the patient¿s serious adverse events.

Event Description

A medwatch form (form fda 3500a) was received by fresenius reporting a hemodialysis (hd) patient on hd therapy experienced an allergic reaction involving facial flushing, restlessness, breathing difficulty and left lower back pain.In the initial reporting, there was no specific allegation the event was related to a deficiency or malfunction of any fresenius device or product.Upon follow-up, the patient¿s hd registered nurse reported the patient experienced an allergic reaction due to a combination of intravenous (iv) mircera and iv venofer during an hd treatment.The patient was using an optiflux 160nre dialyzer on a 2008t hd machine (serial number unknown) in the outpatient clinic at the time of the event.The patient experienced facial flushing, restlessness, breathing difficulty and lower back pain as a result of the allergic reaction and was transported to the emergency department via ambulance.The patient was administered a one-time dose of oral prednisone (dosage unknown) that alleviated the patient¿s symptoms.The patient was not hospitalized for this event and released from the emergency department on the same day.It was confirmed the patient¿s allergic reaction was not due to a deficiency or malfunction of any fresenius device or product.Both mircera and venofer have been discontinued for the patient.The patient has recovered from the event and continues hd therapy on an outpatient basis.

• Brand Name: 2008T MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 10776455
• MDR Text Key: 214329384
• Report Number: 2937457-2020-01983
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/03/2020

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: Health Professional
• Device Catalogue Number: UNKNOWN- 2008T MACHINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OPTIFLUX 160NRE DIALYZER
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 75