MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA HOME HEMO COMBI SET

Catalog Number 03-2962-3

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 09/14/2015

Event Type  Death  

Manufacturer Narrative

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

Event Description

A registered nurse (rn), called into technical support requesting field evaluation on the device after a patient "went into cardiac arrest" during his hemodialysis treatment.His blood was returned, cpr was performed and the patient was transported to the emergency room.Follow up w/the rn indicated this patient was being dialyzed on the k@home at his nursing home.He was admitted there as a result of a cerebral bleed due to a motor vehicle accident.She stated he was under more or less "end of life" care.Prior to his treatment on the date of event, her assessment did not show anything unusual.His treatment time was ordered to be three hours.Approximately 1.5 hours into treatment, he became unresponsive w/no breathing or heartbeat.Up to this point, there were no unusual events or indications of impending cardiac issues.There were no unusual device alarms or product malfunctions nor were any alleged.He expired on (b)(6) 2015.

Manufacturer Narrative

Medical records were received and the results of the clinical investigation reveal the following: on (b)(6) 2015, approximately 1.5 hours into a 3 hour hd treatment, the patient became unresponsive, went into cardiopulmonary arrest, cardiopulmonary resuscitation was administered, the patient was re-infused with all of his blood returned to him, and was transported to an emergency department and admitted to a hospital.On (b)(6) 2015, the patient expired.The received medical record does not contain dialysis treatment records, progress notes, physician orders, or medication records from the even or outcome dates.Laboratory data from (b)(6) 2015 showed bicarbonate 32 result.The received medical records did not contain a death certificate or an autopsy report.There is no documentation in the medical records supporting a possible association between the saline solutions, hemodialysis machine, extracorporeal circuit, dialyzer, acid bath, bicarbonate bag, and the event of cardiopulmonary arrest.The device was not returned to the manufacturer for physical evaluation.The customer was unable to provide the manufacturer with the lot number of the blood lines used in the reported event.As no lot number was provided by th complainant, a record review was performed on each of the lot numbers shipped to the complainant in the three months leading up to the reported event.The batch production records for these lots were reviewed.The batch records confirmed tha released product met specifications; and documented manufacturing process controls were within specification.Per the documented product investigation, there was no indication that the fresenius blood lines caused, contributed to or was a factor in the reported event.

Event Description

Hemodialysis orders - dialysate: 3k+ 2.5ca+ acid bath; machine sodium: 140; machine bicarb 35; dialysate flow rate: 600; blood flow rate 400; dialyzer: f180nr; sodium modeling: no; treatment time: 3 hours.

• Brand Name: HOME HEMO COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; parque industrial reynosa
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5137845
• MDR Text Key: 27917112
• Report Number: 8030665-2015-00469
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 03-2962-3
• Device Lot Number: 15ER01183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 68