MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC NXSTAGE SYSTEM ONE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM

Catalog Number SL-2000M2095

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/17/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing at the time of this report.Return of the product is anticipated but has not been received to date.Upon completion of the evaluation, a supplemental report will be submitted.

Event Description

A report was received on july 23, 2015 regarding a patient who experienced a 250ml blood loss during treatment.During the first 30 minute check, blood was noted to be leaking from the clamped heparin line.The patient was transfused with two units of packed red blood cells.

Manufacturer Narrative

Sl-2000m2095 lot# 50355074 was returned for evaluation.The clamp was able to occlude the tubing without issue.The closed clamp on the tubing line was pressurized, no pressure leak was identified.Dhr review of the clamp lots 50210036 and 50210010 confirmed that there were no defects found during the manufacturing of this lot.No product problem or malfunction was identified.(b)(4).Considers this report closed.No additional information will be provided.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC; 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, b.c. mexico 22180 ; MX 22180
• Manufacturer Contact: paula rogalski ; 350 merrimack street; lawrence, MA 01843 ; 9786874700
• MDR Report Key: 5021635
• MDR Text Key: 23716193
• Report Number: 2919260-2015-00001
• Device Sequence Number: 1
• Product Code: KOC
• 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
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SL-2000M2095
• Device Lot Number: 50355074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• 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): Required Intervention