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

Catalog Number UNKNOWN-2008KMACHINE

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

Patient Problem Death (1802)

Event Date 03/31/2018

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a (b)(6) year old female patient (pt) on in-center hemodialysis (hd) was hospitalized (b)(6) 2018 due to chest pain and elevated troponin levels (unknown values).The pt was not in active treatment at the time of the hospitalization.The pt was assessed for acute coronary syndrome and had a history of chronic obstructive pulmonary disease (copd), chronically elevated troponin levels and heart disease (unspecified).During the hospitalization the pt spiked a fever (date unknown) and went into respiratory failure.The pt was said to have agonal breathing and was transferred to the intensive care unit (icu) and placed on a ventilator.Blood cultures drawn (b)(6) 2018 were positive for staphylococcus and the pt was diagnosed with sepsis.The pt was removed from the ventilator and subsequently went into respiratory arrest.Per the pt¿s family the pt was a do not resuscitate (dnr) and the patient expired on (b)(6) 2018.The cause of death was listed as cardiac arrhythmias and septic shock leading to multi organ system failure.It was stated that the pt received dialysis during hospitalization but there is no documentation the pt was in active treatment or when the last treatment was received.It is also unknown if any fresenius products were utilized.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product.There is no allegation of a machine malfunction.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. .

Event Description

It was reported that patient performing in-center hemodialysis (hd) treatments expired on (b)(6) 2018.Upon follow up, the patient was reported to be hospitalized on (b)(6) 2018 for chest pain and an elevated troponin level and was subsequently admitted.Per the clinical manager, the patient was not admitted to the hospital from the clinic nor was the patient actively dialyzing using any fresenius device(s) when admitted.The clinical manager stated that the patient¿s hospitalization, and subsequent death, was not due to their dialysis therapy.There is no allegation of product deficiency against to any fresenius devices or products related to the reported event.

• Brand Name: UNKNOWN- 2008K 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: 7456612
• MDR Text Key: 106379800
• Report Number: 2937457-2018-01145
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN-2008KMACHINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 04/05/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR