MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number ASKU

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that solution leaked from a hole in the patient line of a homechoice cassette.There was patient involvement.The patient does not use any sharp objects to open her packages.The patient just tears the package open.The patient has a dog but it is old and very unlikely to be the source of the issue.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, fifteen (15) companion samples were received for evaluation.A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.A visual inspection was performed with the naked eye.Functional testing was performed which included leak testing, clear passage testing, clamp function testing, and device-device interaction testing.Functional testing passed with no issues.Visual inspection revealed damaged cassette sheeting on one sample; the other 14 samples had no issues.The reported problem was not verified because leak testing was performed with no issues.One sample did not meet specification.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; ni
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6734665
• MDR Text Key: 80752151
• Report Number: 1416980-2017-06058
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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