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

Catalog Number L5C4531

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Fitting Problem (2183); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that homechoice (hc) cassette was malformed and leaked due to a hole during automated peritoneal dialysis therapy.The home patient (hp) reported that last night when they attempted to connect the patient line of the hc cassette to the transfer set it was unusually difficult to make the connection.Upon doing so, the hp noted droplets of iodine coming from the connection.During the initial drain the hp noticed there were many air bubbles and during filling the hp noticed that fluid leaked out.The hp discontinued therapy and brought the cassette to their registered nurse (rn).The rn noticed that the patient line appeared to be malformed and that the patient line had a hole on the connection where they could feel a plastic melting inside the patient line.There was patient involvement, with no patient injury, however, the hp was given an antibiotic as a preventative measure.No additional information is available.

Manufacturer Narrative

The sample was evaluated.A visual inspection with the naked eye noted a damaged patient connector.Clear passage and clamp function tests were performed with no issues noted.Functional leak testing was performed which revealed a hole inside the patient connector.The reported condition of leak was verified.Only seven (7) inches of patient line tubing to the patient connector with the white clamp was returned; therefore, the reported condition of air bubbles could not be verified.The cause of the condition 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.

Manufacturer Narrative

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 - MOUNTAIN HOME; mountain home AR
• MDR Report Key: 8430470
• MDR Text Key: 139339551
• Report Number: 1416980-2019-01464
• 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,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/03/2023
• Device Catalogue Number: L5C4531
• Device Lot Number: H18K03036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HOMECHOICE; TRANSFER SET