MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number N5C8305C

Device Problem Cut In Material (2454)

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

Event Type  malfunction  

Manufacturer Narrative

The device was received and is in the process of being evaluated.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that eleven (11) homechoice low recirculation volume apd sets with cassette had cuts/slices.The care giver (cg) indicated that the slices had gone through the tubing on all of the reported cassettes and had occurred prior to connecting solutions and prior to connecting the patient.The cg indicated that they discovered these when they were setting up the cycler prior to patient connection.The cg also confirmed that the location of the slices was not consistent to one area of the product and was widespread across the product.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Eleven actual 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 was performed with the naked eye and 10x magnification.There were indentations noted that are known to be caused by the equipment used during manufacturing, but there were no slices, cuts, or holes observed.The observed surface marks are not an indication of a damaged set.Functional testing, including leak testing, clear passage testing, and clamp function testing, was performed with no issues noted.The reported condition of cuts and slices through the tubing was not verified.The product was found to be conforming to specifications.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; mountain home AR
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7475335
• MDR Text Key: 106973998
• Report Number: 1416980-2018-02492
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412087672
• UDI-Public: (01)00085412087672
• 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: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/05/2023
• Device Catalogue Number: N5C8305C
• Device Lot Number: H18A05098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2018
• 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: CYCLER DRAINAGE SET; VIAFLEX RENAL SINGLE CHAMBER APD