MAUDE Adverse Event Report: FRESENIUS NORTH AMERICA HEMO-SAFE; HEMOSAFE

Catalog Number 04-9100-1

Device Problems Disconnection (1171); Connection Problem (2900)

Patient Problems Cardiac Arrest (1762); Death (1802); Blood Loss (2597)

Event Date 10/14/2014

Event Type  Death  

Event Description

This was the pt's 6th hemodialysis treatment.His first after being transferred from icu.Treatment was initiated by cannulation x 2.Md was called several times to come and see the pt while he was on treatment.Unable to sustain an adequate blood flow with new fistula.Per md order, catheter was accessed and blood lines transferred to catheter.Rn stayed with pt for 10 minutes after access was changed.Blood pressure and vs were stable.Rn assessed her second pt in the suite, when she returned to this pt at 12:33pm; she noticed blood on his gown and beside him in the bed.She stopped the blood pump and then attempted to re-secure the venous blood line, at that time the system separated and she quickly re-secured the venous line; hemo-safe device was still attached as per protocol.She then went around the bed to the machine to administer saline for potential volume depletion.During bolus, the pt's heart rate was noted to be dropping from the mid 60's quickly to the 50's and at last check was 46.Code blue button was pushed and crash cart was brought into room.Pt blood was returned prior to the code team arrival.Md notified.Team arrived.Heartrate between 40's and 50's medications administered and pads applied.Decision to call the code was made by md at 12:55pm.

• Brand Name: HEMO-SAFE
• Type of Device: HEMOSAFE
• Manufacturer (Section D): FRESENIUS NORTH AMERICA; waltham MA 02451
• MDR Report Key: 4272870
• MDR Text Key: 5229459
• Report Number: 4272870
• Device Sequence Number: 1
• Product Code: FJK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04-9100-1
• Device Lot Number: 14DRO0600081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2014
• Distributor Facility Aware Date: 10/14/2014
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 77