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 Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tubing of three (3) homechoice cassettes had slices/holes.This issue was identified during setup with patient involvement the care giver indicated that they did not open the container with sharp objects and did not know what had caused the issue.The care giver indicated that they opened the boxes and tape with their fingernail or just by peeling the tape.No further information provided.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction: it was reported that the tubing of four (4) homechoice cassettes had slices/holes.Replaces the previously reported: it was reported that the tubing of three (3) homechoice cassettes had slices/holes.The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Four actual samples were received for evaluation.A visual inspection was performed with naked eye and 10x magnification with no issues noted.There were indentations noted, but no cuts, slices, or holes.Functional testing, including leak testing, clear passage testing and clamp function testing, was performed with no issues noted.The reported issue was not verified.The indentations were a result of the equipment used in manufacturing and the samples were found to be conforming.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: 7394159
• MDR Text Key: 104450532
• Report Number: 1416980-2018-01839
• 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,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2022
• Device Catalogue Number: N5C8305C
• Device Lot Number: H17L08075
• 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
• Patient Age: 17 MO