MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

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

Patient Problems Apnea (1720); Death (1802); Loss of consciousness (2418); Respiratory Failure (2484)

Event Date 08/22/2017

Event Type  Death  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A facility nurse reported a patient had been dialyzing using a fresenius 2008k2 hemodialysis machine for 20 minutes and became unresponsive and stopped breathing due to respiratory failure.The patient was approximately 20 minutes into treatment and became unresponsive and stopped breathing due to respiratory failure.The patient was a known hospice care patient with respiratory issues and had a do-not-resuscitate order, and as such was not resuscitated and expired at the clinic.The rn stated the clinic used fresenius combisets and supplied acid and bicarb concentrates, which were delivered via jugs.The rn stated the facility did not use fresenius dialyzers.The rn stated there was no allegation of any device malfunction, and stated the hemodialysis machine was evaluated by the facility biomed tech and cleared, and all products remain in service without issue.Per rn the associated products and packaging was discarded and was no longer available to be returned for evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res).The unit was pulled from service for evaluation by the facility biomedical engineer (biomed) following the event.The machine did not require any repairs and was confirmed to be operating properly.The unit has been returned to service at the user facility without a recurrence of the event as reported.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances or any associated rework during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the results of the in progress and final quality control (qc) testing met all requirements.The investigation into the cause of the patient incident was not able to confirm a device issue which would have resulted in the adverse event.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A facility nurse reported a patient had been dialyzing using a fresenius 2008k2 hemodialysis machine for 20 minutes and became unresponsive and stopped breathing due to respiratory failure.The patient was approximately 20 minutes into treatment and became unresponsive and stopped breathing due to respiratory failure.The patient was a known hospice care patient with respiratory issues and had a do-not-resuscitate order, and as such was not resuscitated and expired at the clinic.The rn stated the clinic used fresenius combisets and supplied acid and bicarb concentrates, which were delivered via jugs.The rn stated the facility did not use fresenius dialyzers.The rn stated there was no allegation of any device malfunction, and stated the hemodialysis machine was evaluated by the facility biomed tech and cleared, and all products remain in service without issue.Per rn the associated products and packaging was discarded and was no longer available to be returned for evaluation.

Manufacturer Narrative

Conclusion: a temporal relationship exists between this elderly patient¿s unresponsive episode with reported respiratory failure and ultimate patient death and hd treatment with fresenius products.There is no documentation in the complaint file to support a causal association between fresenius products and the patient¿s death.Additionally, there have been no reported allegations of a fresenius product device malfunction causally associated to the patient event.The etiology of the patient¿s respiratory failure is unknown.However, the patient was reportedly in hospice care concomitantly with pre-existing respiratory issues.Additionally, the patient had a do not resuscitate order in place preventing resuscitative interventions at the time of the incident which is likely associated to the patient¿s ultimate death.

Event Description

Information in the complaint file was reviewed by a post market surveillance clinician.On (b)(6) 2017, this patient with end stage renal disease (esrd) on hemodialysis (hd) therapy began hd treatment at 6:37am central daylight time (cdt) and subsequently stopped breathing (reportedly from respiratory failure) and became unresponsive approximately 20 minutes into hd treatment (at 7:00am cdt).Hd treatment details prior to event were unknown.The etiology for the patient¿s respiratory failure was unknown.Reportedly, the patient was not resuscitated during the incident as the patient was on hospice services and had a do not resuscitate order in place.As a result, the patient subsequently expired during hd treatment.The nurse who reported the event stated no machine alarms occurred at the time of the incident.Additionally, the nurse reported (on (b)(6) 2017 during a follow up call), evaluation/testing of the k2 machine (after the event) by the biomedical technician at the user facility (unknown date) cleared the machine to be returned to service.There were no reports of any machine or other fresenius product repairs required in relation to the patient incident.Furthermore, the nurse reported there were no allegations of any fresenius device malfunction associated with the pt¿s death and all products remain in service without any reports of further issues.

• Brand Name: 2008K2
• 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: 6888067
• MDR Text Key: 87158631
• Report Number: 2937457-2017-00948
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2012
• 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; Life Threatening
• Patient Age: 82 YR