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

Catalog Number 5C4471R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Type  Injury  

Manufacturer Narrative

Complaint no: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the patient experienced a heart attack coincident with automated peritoneal dialysis (apd) therapy.On an unreported date, the patient was hospitalized for the event.Treatment for the event was not reported.The report indicated that apd therapy was ongoing.Patient outcome was not reported, and the patient was still hospitalized at the time of this report.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation; however, the serial number of the device was identified.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE
• 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 almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5390983
• MDR Text Key: 36821250
• Report Number: 1416980-2016-01890
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

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: 5C4471R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2016
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• 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
• Patient Outcome(s): Hospitalization