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

Catalog Number 5C4469C

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that thirty (30) homechoice automated pd sets with cassette were damaged.The damage was further described as a crack in an unspecified location near the cassette.The damage was discovered prior to use for peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: d9, h3, h6.H10: thirty-six (36) samples were received for evaluation with original caps attached to the connector, uncoiled or tangled together inside a master carton.A visual inspection was performed with the naked eye which did not observe the reported condition of cracks.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The samples met specifications.The reported condition of 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.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 CORPORATION; deerfield IL
• MDR Report Key: 11394440
• MDR Text Key: 234217977
• Report Number: 1416980-2021-00948
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412087375
• UDI-Public: (01)00085412087375
• Combination Product (y/n): Y
• PMA/PMN Number: K923065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4469C
• Device Lot Number: H20E05061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1