MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2722-9

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

Patient Problem Death (1802)

Event Date 02/13/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.The plant investigation is in process.A supplemental mdr will be submitted at the completion of this activity.

Event Description

A facility acute coordinator registered nurse (acrn) provided follow-up information which revealed that an (b)(6) chronic end stage renal disease patient was being dialyzed in the acute hospital setting.The patient, who was unable to talk or move due to a previous stroke, was admitted for aspiration pneumonia.The patient also received tube feedings while hospitalized.According to the acrn, prior to the treatment, the patient was in what was considered to be a normal state of health.At 9:24 am, approximately 1.5 hours into treatment, the patient appeared "different." the patient's blood pressure was found to be low and was noted as being approximately 80/54.The patient, who was not on a ventilator, appeared to be struggling to breathe.Both the acrn and the physician suctioned the patient, and then the treatment was terminated, and all blood was returned.The acrn administered a 300ml normal saline solution bolus due to the hypotension.At approximately 9:45 am, the patient stopped breathing and expired.The patient had a do not resuscitate order; therefore, cardiopulmonary resuscitation was not performed.Following the event, the hemodialysis machine was removed from service for evaluation.The biomedical technician found the unit's ultrafiltration to be out of calibration.The unit remains at the user facility.No parts are available for return to the manufacturer for analysis.

Manufacturer Narrative

The results of the clinical investigation are as follows: a fresenius regional equipment specialist evaluated the device at the facility.According to the service documentation, the ultrafiltration (uf) pump was found to be out of tolerance by approximately 0.3 ml.Although the uf pump was found to be out of calibration, this nominal value is not thought to be a causal or contributory factor in this event.There is no documentation in the medical record supporting a possible association between the fresenius products, and the event of hypotension, and outcome of death.Plant investigation: the complainant facility was unable to provide a sample for evaluation.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.Review of the batch production record did not reveal a probable cause for the customer complaint.Dhr review was performed.No nonconformance reports or other abnormalities during the assembly of related lot were found.Based on this, it is concluded the product involved met current specifications.Therefore, the reported complaint is not confirmed the system level review of the 2008k2 device and concomitant products found no indication that the products caused or contributed to the clinical event.

Event Description

Based on the 70 pages of medical records information it appears that this (b)(6) male esrd patient on intermittent hd therapy being carried out daily through fresenius products, started dialysis therapy on an unknown date.On (b)(6) 2016, the patient was admitted to a hospital with fever and found to have mucous plugging and complete atelectasis of the left lung.The patient, who was unable to talk or move due to a previous stroke, was diagnosed with aspiration pneumonia, and received tube feedings while hospitalized.According to the acrn, prior to the treatment, the patient was in what was considered to be a normal state of health.During hd treatment on (b)(6) 2016, at 9:24 am, approximately 1.5 hours into treatment, the patient appeared "different." the patient's blood pressure was found to be low and was noted as being approximately 80/54.The patient, who was not on a ventilator, appeared to be struggling to breathe.Both the acrn and the physician suctioned the patient, and then the treatment was terminated, and all blood was returned.The acrn administered a 300ml normal saline solution bolus due to the hypotension.At approximately 9:45 am, the patient stopped breathing and expired.The patient had a do not resuscitate order; therefore, cardiopulmonary resuscitation was not performed.Following the event, the hemodialysis machine was removed from service for evaluation.The biomedical technician found the unit's ultrafiltration to be out of calibration.The unit remains at the user facility.No parts are available for return to the manufacturer for analysis.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5507652
• MDR Text Key: 40576912
• Report Number: 8030665-2016-00123
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15LR01263
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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
• Treatment: FRESENIUS HEMODIALYSIS MACHINE
• Patient Outcome(s): Death
• Patient Age: 88 YR
• Patient Weight: 73