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 Death (1802); Dyspnea (1816); Loss of consciousness (2418); Diaphoresis (2452)

Event Date 01/21/2020

Event Type  Death  

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 hd therapy utilizing the fresenius 2008t hemodialysis machine and the serious adverse events of an anaphylactic reaction (characterized by eyes widening, diaphoresis and dyspnea), loss of consciousness and subsequent death following the administration of vancomycin following hd therapy.Per the xellia (representative reporting the events), the patient¿s biomedical/medical team concluded no fresenius product(s) and/or device(s) caused or contributed to the patient¿s serious adverse events or death.Anaphylaxis is a rare and life-threatening allergic reaction, which can be caused by severe drug reactions.Based on the information available, the fresenius 2008t hemodialysis machine can be disassociated from the events.There is no allegation or objective evidence indicating a fresenius product(s) or device(s) deficiency or malfunction, caused or contributed to the serious adverse event(s) experienced by the patient.Furthermore, the 2008t hemodialysis machine passed all post event functional compliance and was returned to service by the biomedical/medical team.

Event Description

It was reported to fresenius that a hemodialysis (hd) patient experienced anaphylactic shock and subsequently expired, post-treatment after receiving intravenous (iv) vancomycin (not a fresenius product).A medwatch report received from xellia (manufacturer) stated the events were unrelated to any fresenius products.Following treatment, the patient reportedly complained of chills, and the nephrologist ordered blood cultures and an intravenous (iv) dose of vancomycin 2000 mg.Within minutes of beginning the infusion, the patient experienced facial flushing, eyes widening, diaphoresis, trouble breathing (dyspnea) and subsequently lost consciousness.The vancomycin infusion was immediately stopped, and cardiopulmonary resuscitative (cpr) measures were instituted.911 was contacted, emergency medical services (ems) arrived, and the patient was transported to the hospital.Although the hospital course is largely unknown, the medwatch states the patient expired four days later.Additional details were provided via follow-up with the user facility.The hd machine was immediately sequestered following the events.Functional compliance testing was performed on the 2008t hd machine as per manufacturer specifications.The biomedical/medical team approved returning the 2008t hemodialysis machine to service following the favorable test results.It was concluded no fresenius product(s) and/or device(s) caused or contributed to the patient¿s serious adverse events.Additionally, monthly culture and endotoxin levels collected at the hospital returned showing no growth.The serial number for the hd machine is unknown as it was not provided during follow-up.

• 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: 10754565
• MDR Text Key: 213639018
• Report Number: 2937457-2020-01951
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- 2008T MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/09/2020
• 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
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 102