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

Catalog Number	N5C8305C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported twenty-five (25) low recirculation volume apd set with cassettes appeared damaged.The event was further described as the devices ¿either had a noticeable sliced hole or a scratch mark varying in severity¿.The events occurred during unspecified process steps while performing peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: seventeen (17) devices were received for evaluation.During visual inspection, scuff/scratches were observed on the drain line tubing next to the track welds.The sets underwent functional testing; including leak, clear passage and clamp function testing, and the sets performed according to product specification.No leaks or holes were noted.The scuff/scratches are cosmetic in nature and do not affect the functionality of the devices.Therefore, there was no risk to the patient as the scuff/scratches on the tubing did not result in a breach in the sterile pathway.The reported condition was verified.The cause of the condition was determined to be manufacturing related, caused by tubing grippers during the automated assembly process.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
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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 ; 2242702068
• MDR Report Key: 15667501
• Report Number: 1416980-2022-05690
• Device Sequence Number: 7169869
• Product Code: FKX
• UDI-Device Identifier: 00085412087672
• UDI-Public: (01)00085412087672
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K102936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/09/2026
• Device Catalogue Number: N5C8305C
• Device Lot Number: H21H09074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown