MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number ASKU

Device Problems Crack (1135); Fluid/Blood Leak (1250); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2019

Event Type  malfunction  

Manufacturer Narrative

An alarm indicative of a potential malfunction of the disposable cassette was reported.The device was discarded and the lot number is unknown; therefore, a device analysis could not be completed.However, a leak was reported between the supply line of the homechoice cassette and the supply bag, which is known to cause this alarm.The cause of the leak could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during dwell three of five of peritoneal dialysis therapy.During the troubleshooting, it was reported that there was a leak between the supply line of the homechoice cassette and the supply bag that led to this alarm.It was further reported that there was crack in the solution bag connector of the cassette (interface with the disposable set and the solution bags).Renal therapy services (rts) assisted with clearing the alarm and advised to restart therapy with all new supplies.Proper procedures per the user manual were reviewed with the caregiver.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction : the device manufacturer name and address were changed from baxter healthcare - mountain home to baxter healthcare corporation of an unspecified manufacturer address location.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; mountain home AR
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 1900 n highway 201; ni; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8848756
• MDR Text Key: 152909180
• Report Number: 1416980-2019-04216
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1