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 Cardiac Arrest (1762); Death (1802); Dyspnea (1816)

Event Date 09/30/2018

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.

Event Description

A clinical administrator at a user facility reported that on (b)(6) 2018 a hemodialysis (hd) patient called emergency medical services (ems) for shortness of breath. The clinical administrator stated that it was reported that when ems arrived, the patient went into cardiac arrest. Resuscitation efforts were unknown. The patient was brought to the hospital via ems and subsequently expired that same day. The clinical administrator stated that the patient was not actively dialyzing at the time of the event. The patient¿s last dialysis treatment was unknown. The clinical administrator was unaware of the patient¿s cardiac history, however reported that the patient was newly diagnosed with chronic obstructive pulmonary disease (copd). The patient tested (b)(6) in the hospital for cannabis and opiates as well. The clinical administrator confirmed that there was no allegation of product deficiency or malfunction of any fresenius device(s) or product(s) related to the patient¿s death. Additionally, amber stated that the patient¿s death was unrelated to their hemodialysis (hd) therapy.

Manufacturer Narrative

Additional information: clinical investigation: it was reported that on (b)(6) 2018 the hemodialysis (hd) patient became short of breath and emergency medical services (ems) was summoned. The patient was not in an active hd treatment when the event occurred (time of last hd treatment is unknown). It was stated the patient subsequently went into cardiac arrest when ems arrived on scene. The patient was taken to the hospital (resuscitative efforts are unknown) and subsequently expired. Per the clinical administrator associated with the patient, the patient was recently diagnosed with chronic obstructive pulmonary disease and had a known history of opiate drug abuse. Per the reporter, the patient tested positive for opiates and cannabis with toxicology testing at the hospital. There were no reported allegations of any fresenius device or product associated with the patient¿s death. The reporter indicated the patient¿s death was unrelated to hd therapy. There is no objective evidence that reasonably suggests the patient¿s cardiac arrest and subsequent death were caused by the 2008t machine or hd therapy. It was reported the patient was not actively dialyzing when the event occurred. Furthermore, the patient had a history of drug abuse. It was reported the toxicology results indicated the patient was positive for opiates and cannabis which is a likely cofounding factor in the patient¿s shortness of breath which progressed to cardiac arrest and 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.

• Brand Name: 2008T MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 8002573
• Report Number: 2937457-2018-03191
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Catalogue Number: UNKNOWN- 2008T MACHINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 10/29/2018
• 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 Age: 57 YR
• Patient Weight: 52
• Patient Outcome(s): Death; Hospitalization; Required Intervention