MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CRIT-LINE BLOOD CHAMBER

Catalog Number CL10021021

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/05/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the complaint sample.A product recall has been initiated by the manufacturer and the reported product issue is being investigated by the manufacturer via a capa.Medical records were provided and have been reviewed by post market clinical staff.Based on the 43 pages of medical records information it appears that on (b)(6) 2015, this patient was admitted into the hospital following a blood loss during hemodialysis.According to the medical records, the patient had a 500cc blood loss due to leak between the dialyzer and critline chamber.The physician notes state that the clip from her dialysis line came loose.Physician notes state there were no trauma.Physician notes stated the patient was in her usual state of health at the time of dialysis.Patient was noted to have left upper extremity edema.There is no documentation that shows patient required a blood transfusion.In addition, the patient has a diagnosis of anemia.The clinic manager stated that the critline did not fully disconnect but had a poor connection.The nurse was trained in operating the crit-line and there was no user error.According to medical records, 30 minute safety observable checks were performed of the entire extracorporeal circuit to ensure bloodlines, connections and needles were secured.However, the clinic manager stated that the crit-line was leaking blood for a little while.Medical records reveal the machine did not alarm.Medical records reveal the nvl enabled, pht test passed, high flux verified, air detector armed and alarms verified.

Event Description

The following was reported via a user facility medwatch: a hemodialysis user facility reported that during treatment a blood leak occurred.Blood was visually seen leaking out of the top of the dialyzer where the critline blood chamber was connected.The following is based on medical records provided by the user facility: the patient's pre-dialysis vital signs were documented as: blood pressure= 126/63, pulse= 60 (regular), respirations= 16 and temperature= 98.4.A nurse visually observed the leak at the connection of the critline blood chamber and the dialyzer, at 2 hours and 40 minutes into hemodialysis therapy.The nurse reported blood was seen on the floor and noticed to be leaking out of the top of the dialyzer where the critline blood chamber was connected.The patient estimated to have blood loss of 500cc.The critline blood chamber did not become disconnected.Patient was unresponsive to verbal stimuli and sternal rub for approximately 5 seconds.Normal saline was opened and the critline sensor was secured.The patient was placed on oxygen via mask at 5 liters per minute and the patient's blood pressure was 123/34.The patient was administered 500cc normal saline and the patient became alert, responsive had a blood pressure off 124/68 and pulse was 64 (regular).The patient arrived at the emergency room with concern for a syncopal episode as the patient did not remember going unconscious or being lightheaded or dizzy.The patient was admitted and continued on intravenous fluids and had amlodipine discontinued.Patient was discharged the next day and diagnosed with syncope, likely secondary to hypotension and result of blood loss.

• Brand Name: CRIT-LINE BLOOD CHAMBER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; kaysville UT
• Manufacturer (Section G): HEMA METRICS DIVISION; 695 n 900 w; kaysville UT 84037
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5221762
• MDR Text Key: 31186699
• Report Number: 2937457-2015-01592
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935958
• 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
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Catalogue Number: CL10021021
• Device Lot Number: 14111311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• 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
• Removal/Correction Number: Z-1716-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 59