MAUDE Adverse Event Report: GAMBRO LUNDIA AB BICART; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number BICART 720G

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/29/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The bicart product involved in this incident was discarded and not available for investigation.

Event Description

A home dialysis patient in (b)(6) was found deceased.The patient was connected to the dialysis machine which was still turned on and involved polyflux 21 l dialyzer.The patient allegedly performed his dialysis treatment at home without any supervision.The patient was allegedly found in supine position in a 45º degree angle in his chair with the extracorporeal circuit full with blood.

• Brand Name: BICART
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): GAMBRO LUNDIA AB; box 10101; lund SE-22 010; SW SE-22010
• Manufacturer Contact: anja sandberg ; box 10101; lund ; SW ; 46169381
• MDR Report Key: 5460848
• MDR Text Key: 39035247
• Report Number: 9616023-2016-00001
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K013724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2016

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 Expiration Date: 07/31/2017
• Device Model Number: BICART 720G
• Device Catalogue Number: 109733
• Device Lot Number: 55180
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: POLYFLUX 21L
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 86