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

Catalog Number R5C4479

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6) the sample was received without the pouch.A visual inspection was performed with the naked eye which found cracks at the side of the welded cassette.An underwater pressure test was performed which revealed a leak at the crack location.The sample failed to meet product specifications.The reported condition was verified.The cause of the condition could not be determined, however, a potential cause was noted to be if the cassette came in contact with solvent like alcohol during sterilizing.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.

Event Description

It was reported that the "rectangular plastic piece" of a homechoice automated pd set with cassette was cracked.This was identified by the patient at home prior to use for automated peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 11802962
• MDR Text Key: 251870937
• Report Number: 1416980-2021-02794
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412030531
• UDI-Public: (01)00085412030531
• Combination Product (y/n): Y
• Reporter Country Code: TW
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C4479
• Device Lot Number: S21A10126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1