MAUDE Adverse Event Report: MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY); BLOOD TUBING SETS

Model Number B3-6604M6792

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

The device was not retained for investigation.The design history file for the cartridge lot number was reviewed and met all requirements in the manufacturing process prior to release with no related defects.Dialysis is performed by trained and qualified personnel who provide continuous monitoring and check for leaks during treatment in order to respond to alarms and potentially harmful conditions promptly.The user guide warns that the use of sets with priming volumes that exceed 10% of patients blood volume can result in hypovolemic shock or death.

Event Description

A report was received on october 18, 2016 of an (b)(6) -old patient who experienced a blood loss of approximately 50ml from a leak in the blood tubing set during treatment.The patient received 90ml of albumin, 60ml of packed red blood cells (prbc's) and prophylactic vancomycin.The patient continues to treat and was reported to be stable.

• Brand Name: MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY)
• Type of Device: BLOOD TUBING SETS
• Manufacturer (Section D): MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY); 350 merrimack street; lawrence MA 01843
• Manufacturer (Section G): MEDIMEXICO S. DE R. L. DE C. V; av. valle imperial no. 10523; parque industrial valle sur; tijuana 22180 ; MX 22180
• Manufacturer Contact: paula rogalski ; nxstage medical, inc; 350 merrimack street; lawrence, MA 01843 ; 9786874700
• MDR Report Key: 6103296
• MDR Text Key: 59967780
• Report Number: 2919260-2016-00005
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/18/2016

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: 04/30/2017
• Device Model Number: B3-6604M6792
• Device Catalogue Number: BTL, 6.35MM, POST-PUMP LOW FLO
• Device Lot Number: 40451001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 MO
• Patient Weight: 9