MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET 2008

Catalog Number 03-2722-9

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

Patient Problems Death (1802); Blood Loss (2597)

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

Plant and clinical investigations have not yet been completed.A follow up report will be filed upon completion of the investigations.

Event Description

A hemodialysis inpatient user facility reported that a patient care technician attempted to cannulate the arterial site and re-adjust the arterial needle to obtain blood flow.At the time of initiating treatment, the arterial chamber was filed with saline but when blood reached the arterial chamber it started emptying and filling with air.The machine alarmed and technicians attempted to assess and troubleshoot by raising the level of the arterial chamber with saline.The patient had what appeared to be a seizure and then lost consciousness.At the time, staff observed an empty saline bag and air in the dialysis lines.Staff placed the patient in trendelenburg position on left side, applied oxygen and called 911.Approximately 250cc of blood was lost during the treatment as the patient's blood was not rinsed back.The patient was taken to the hospital and remained in the hospital's intensive care unit from (b)(6) 2015, when she expired.No samples are available for evaluation.

Manufacturer Narrative

Medical records were reviewed and concluded on (b)(6) 2015, the patient had an unresponsive episode during her hemodialysis treatment.Peritoneal dialysis registered nurse (pdrn) confirmed the incident.She said the patient was put on the machine and lost consciousness within minutes afterwards.She said the patient was also using an optiflux 180nre and saline, both manufactured by fresenius.Patient was on the optiflux 180nre and saline without any adverse events on (b)(6) 2015.Pdrn said there were no leaks.After the patient lost consciousness she was transported to the hospital by ambulance.According to the pdrn, approximately 250ccs of blood was lost during the treatment.The pdrn stated the patient remained in the hospital's intensive care unit from (b)(6) 2015, when she expired.The pdrn stated the dialysis machine was pulled for further evaluation.According to the emergency room staff, the patient was alive when she was at the emergency room.Medical records do not contain a hospital admission diagnosis nor a history and physical.Medical records do not contain a death certificate or autopsy report for review.Medical records do not reveal the patient expired.The medical records do not contain hospital progress notes, lab/diagnostic reports, physician orders, and dialysis treatment sheets for review.Medical records do not indicate that there was a causal relationship between the air in the line and the patient's hospitalization and alleged death.Medical records do not reveal cause of patient's death medical records do not reveal the dialysis products used while the patient was hospitalized.Medical records do not reveal whether the patient was on dialysis during her death.Plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

Event Description

Medical records: hemodialysis orders (b)(6) 2015' 180nre optiflux.Olc-v- 31 01.Dfr: autoflow 1 5.Dialysate composition- 3.0k, 2.5ca, 1.0mg, 100 dextrose.Sodium (meq/l): 137.Bicarb machine setting (meq/l): 30.Scheduled hours: 3.45.Blood volume processed: 90.0.Sodium modelling method none.Estimated dry weight: 82.00, 20008t machine.Machine cond 13.8.Meter cond 13.7, ph: 7.1.Machine temp: 37.0.

Manufacturer Narrative

The complaint is deemed as unconfirmed.The actual sample was not available and the lot number of product involved in this incident is unknown.A three month sales and shipping search to the client site demonstrated lot 15dr0 112.Alternate samples were returned to the manufacturing facility from the distribution center for evaluation.The sample tested met the acceptance criteria no issues were detected during functional eval.An investigation of the manufacturing records was also conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process in addition, the batch record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: CUSTOM COMBI SET 2008
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps 88790 ; MX 88790
• Manufacturer Contact: dianne chin ; 7816999105
• MDR Report Key: 5032725
• MDR Text Key: 24354595
• Report Number: 8030665-2015-00382
• 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: Other
• Type of Report: Followup,Followup
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2015
• 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
• Patient Age: 60 YR
• Patient Weight: 86