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

Catalog Number 5C8310

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Heart Failure (2206)

Event Date 01/29/2014

Event Type  Death  

Event Description

It was reported that a patient passed away coincident with peritoneal dialysis (pd) therapy.The cause of death was cardiac failure.The patient was not hospitalized prior to death.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

(b)(4).The device is reported to be available for evaluation.Should the device be returned or additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The investigation of the device was unable to determine a cause for the reported event.Should additional relevant information become available, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).The device was received for evaluation by the baxter product analysis laboratory (pal).A review of the service history and the event history log was performed.Upon performing these reviews, no issues were found that could be related to the reported event.The device was tested and passed both the homechoice return instrument test/ evaluation (rite) functional test and the rite electrical test.The device was determined to meet functional and electrical performance specification requirements.An external & internal inspection was performed which revealed no anomalies.An evaluation of the device pneumatic system revealed no leak and all pressures were correct & stable.A short simulated therapy was performed successfully.Per pal evaluation, there was no failure, malfunction or iipv (increased intraperitoneal volume) event identified that could have caused or contributed to the reported issue of patient passing away.A device history record review was performed, and no issues were found related to the reported condition.Should any relevant information be obtained from this review that is related to the reported event or through other means, 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3685707
• MDR Text Key: 4241514
• Report Number: 1416980-2014-08897
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 03/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/14/2014; 05/12/2014
• 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 1.5% PD4 AMBUFLEX; DIANEAL 1.5% PD4 ULTRABAG
• Patient Outcome(s): Death
• Patient Age: 67 YR