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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); Blood Loss (2597)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon final review of medical records by post market clinical staff and completion of the plant's investigation.

Event Description

A user facility reported that during hemodialysis therapy, a patient's catheter needle became dislodged and resulted in 500ml of blood loss.The machine did not alarm.The patient did not complete treatment and was administered 800 ml saline.The patient experienced hypotension which did not resolve with the administration of saline, and was taken to the hospital.The patient did not remain hospitalized overnight and was discharged without further complications the sample was not available.

Manufacturer Narrative

Medical records were provided and have been reviewed by post market clinician staff.Based on the 42 pages of medical records info.It appears that this is a (b)(6) male esrd pt on hd therapy who on (b)(6) 2015 was presented to an emergency department due to blood loss and hypotension, was given a fluid bolus, observed on a cardiac monitor, and was not transfused due to his hemoglobin not being sufficiently low.On (b)(6) 2015, the pt was discharged from the emergency department alert and oriented times three.There is no documentation in the medical record supporting a possible association between the hd machine, the extracorporeal circuit, and the event of blood loss.However, there is a certain association between the event and the episode of venous needle dislodgement.Further info has been solicited.

Event Description

Hemodialysis orders from (b)(6) 2015 included: f180nre optiflux dialyzer; dialysate flow rate auto flow 2.0, blood flow rate 450, 2 potassium, 2.5 calcium, 1 magnesium, 100 dextrose, sodium 137meq/l, treatment time 4.5 hours, estimated dry weight 125kgs, access left above elbow arteriovenous fistula.On (b)(6) 2015 at 10:54am, the hd treatment was initiated without any difficulty.At 3:24pm, the venous needle became dislodged, the machine never alarmed and the blood pump kept running, approx less than 500ml's of blood loss occurred, and 800ml's of normal saline was administered, making the ultrafiltration goal for the treatment a net negative 1893ml.At 4:11pm, the pt's vitals were 88/46 blood pressure, pulse 122, on 2l/min oxygen, in trendelenburg position, arterial and venous cannulation sites clotted, and the pt was transported to a hospital's emergency department via emergency medical services.The pt was treated with mircera.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past 3 months.Batch records for the eight lots identified were reviewed and confirmed there were no deviations or non-conformance's 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
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque industrial reynosa; reynosa, tamps 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5297468
• MDR Text Key: 33527440
• Report Number: 8030665-2015-00590
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• 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: Initial,Followup,Followup
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 123