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

Catalog Number R5C4479

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a small bump or roughness located one centimeter left from the lower right corner of a homechoice automated pd set with cassette.This issue was observed before use by the patient and her nurse.The customer was afraid that this irregularity in material could develop into a hole during therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation and an evaluation is complete.A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.A visual inspection was performed with the naked eye and magnification which revealed a small scratch and indentation in the cassette sheeting.Microscopic inspection showed that this scratch was not a cut.Functional testing was performed which included a simulated therapy.The sample did not leak and therapy was completed without any alarms or issues.The reported condition was verified.An assignable cause of the scratch could not be determined.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 - SINGAPORE; singapore
• 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 60073 ; 2242702068
• MDR Report Key: 6733940
• MDR Text Key: 80716816
• Report Number: 1416980-2017-06038
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• 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: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• 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: S16L08084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2017
• 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