MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME EXTENSION SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number 5C4480C

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2015

Event Type  malfunction  

Event Description

It was reported that a patient discovered a leaking extension set.This occurred during priming of peritoneal dialysis therapy.The patient was not connected at the time of the event.The patient stated that the leak was noticed "from the end of the extension set that has the cap on it." the patient confirmed that it was leaking from the end that they would normally connect to their transfer set.The patient stated there was no noticeable damage to the product or overpouch.The patient stated they were able to complete therapy by starting over with all new supplies.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Additional information: the device was received for evaluation.A visual inspection was performed and identified no issues.Functional testing of the device included leak testing, clear passage testing and pressure testing; functional testing identified no issues were identified that could have caused or contributed to the reported problem.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.The reported issue was not verified, and the cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SET
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4860257
• MDR Text Key: 5872765
• Report Number: 1416980-2015-26172
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/21/2020
• Device Catalogue Number: 5C4480C
• Device Lot Number: H15C21045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 111