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 event/therapy occurred on an unspecified date in (b)(6) 2018.The device was received and evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that three (3) homechoice low recirculation volume apd sets with cassette had cuts/slices in the tubing.This issue was identified during setup prior to connection.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Two devices were received for evaluation.The received units had been removed from the package but had not been used as evidenced by the presence of the paper tape on the unit, the presence of all protective caps, and the lack of any fluid in the disposable units.The care giver indicated that the units had slices after removal from the packaging which were noticed during setup.Most units were marked in multiple locations with a black marker by the cg where the reported damage appeared to be present.A visual inspection was performed with naked eye and 10x magnification which noted minor indentations and scratches, but no cuts or slices.Functional testing, including leak testing, clear passage testing and clamp function testing, was performed with no issues noted.The reported problem was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported problem was not verified.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: 7484547
• MDR Text Key: 107326300
• Report Number: 1416980-2018-02574
• 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: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: N5C8305C
• Device Lot Number: H17I11116
• 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: 05/09/2018
• 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