MAUDE Adverse Event Report: BAXTER HEALTHCARE - SWINFORD OUTLET PORT CLAMP; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number SPC4527

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous ambulatory peritoneal dialysis (capd) therapy, the patient had a leak when they were using the outlet port clamp.The patient stated that they clamped the drain line, but noted that even though they have clamped the line, solution was still leaking out.The clamp was new and the patient went to use the clamp at the end of dialysis.After clamping the line, the fluid was seeping through where the clamp was and had dripped out the end onto work surface.As a result, the patient used multiple clamps to pinch the line.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: the actual device and companion samples were received for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed with no issues noted.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: OUTLET PORT CLAMP
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SWINFORD; swinford
• Manufacturer (Section G): BAXTER HEALTHCARE - SWINFORD; foxford road; ni; swinford ; EI
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6117122
• MDR Text Key: 60548602
• Report Number: 1416980-2016-17499
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: SPC4527
• Device Lot Number: 15J01H80
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TWIN BAGS