MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C8310R

Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198); Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

It was reported that a homechoice device caught on fire and had melted.This occurred during an unknown step of peritoneal dialysis.The patient was not connected to the device.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was received for evaluation.A review of the event log was performed.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.A visual inspection was performed.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.No burning or melting was observed.There were no signs of melting anywhere on or in the machine, however it appeared that the device had suffered excessive impact resulting in damaged external components.The device was scrapped for this reason.The direct cause of the problem was undetermined.Should additional relevant information become available a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Additional follow up with the patient was performed.The patient clarified the previous report that the homechoice caught on fire and/or melted, stating that this event did not happen and that the issue was the device¿s display not working properly.(b)(4).Conclusion code will be replaced with conclusion code and results code will be replaced.During device testing, the device failed the display verification test.The reported condition was verified.The cause was determined to be a dislodged zodiac cable due to severe impact.The device was scrapped.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: kinga almasam ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4693813
• MDR Text Key: 15896521
• Report Number: 1416980-2015-16823
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DIANEAL AMBUFLEX PD4 2.5%
• Patient Age: 29 YR