MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number R5C4479C

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint no: (b)(4).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was found that there was a leak from holes in the cassette sheeting of a homechoice automated pd set with cassette.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 for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A visual inspection was performed and holes were observed in the cassette sheeting.Clear passage testing, clamp function testing and device-device interaction testing were all performed.Leak testing was performed and confirmed the reported issue.The cause of the issue was determined to be puncture or tear in cassette sheeting.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• 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: 5042565
• MDR Text Key: 24615804
• Report Number: 1416980-2015-34313
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C4479C
• Device Lot Number: H15E01091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• 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: 59 YR