MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number UNKNOWN- FMC BLOODLINE

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

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

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.

Manufacturer Narrative

The complaint sample is not available and the lot number of product involved is unknown.Therefore a search on sap system was performed of the lots delivered to the facility, with a time frame of three months before of the event date.No information was found from the bloodlines device products.Consequently no product will be returned from the distribution center to be analyzed since the lot number is unknown and no information was found on the sap system from this customer regarding to the bloodlines device products.No device history review was performed since the lot number is unknown and no information was found on the sap system from this customer related to bloodlines device products.In addition there are no product malfunction reported, with the information available in the complaint file, it is not possible to determine a causal relationship between the product and the incident.

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 6:37 am central daylight time (cdt) and subsequently stopped breathing (reportedly from respiratory failure) and became unresponsive approximately 20 minutes into hd treatment (at 7:00 am 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 09/15/2017 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: FMC BLOODLINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6888046
• MDR Text Key: 87158858
• Report Number: 8030665-2017-00753
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• 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: 10/22/2017

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
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN- FMC BLOODLINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 82 YR