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

Catalog Number L5C4531

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient experienced air in the patient line of a homechoice cassette without an alarm.This occurred during priming for peritoneal dialysis (pd) therapy.The patient was connected at the time of the event.There was nothing unusual found during troubleshooting that would cause or contribute to the event; however, it was reported that the patient had repeatedly re-primed the set and still the patient had air enter their system causing pain.There was no physical damage or kinks in the set; however, the patient believed this issue was caused by something wrong inside the tubing of the cassette.The patient ended their therapy session and did not complete pd therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3, and h6.H10/h11: two (2) companion samples and six (6) actual samples were received for evaluation.A visual inspection was performed, and it was noted that indentation was observed on the cassette sheeting of five samples.Warpage was also observed on one cassette that had indentation.For three samples, visual inspection did not identify any abnormalities that could have contributed to the reported condition.Leak testing, clear passage testing, and clamp testing was performed with no issues noted with any of the returned samples.A simulated therapy was performed using all the returned samples, and it was noted that three of the returned actual samples completed testing with no issues.Five returned samples failed during the priming stage.Of the eight returned devices, the reported condition was verified for five samples.The reported condition was not verified for 3 returned samples.The cause of the indentations on the samples and warped cassette was determined to be manufacturing related.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: 9972682
• MDR Text Key: 188045589
• Report Number: 1416980-2020-02232
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412090078
• UDI-Public: (01)00085412090078
• Combination Product (y/n): N
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: L5C4531
• Device Lot Number: H19J30048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DIANEAL LOW CA 1.5%; DIANEAL LOW CA 2.5%; DIANEAL LOW CA 4.25%; HOMECHOICE; DIANEAL LOW CA 1.5%; DIANEAL LOW CA 2.5%; DIANEAL LOW CA 4.25%; HOMECHOICE
• Patient Age: 55 YR