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

Model Number BICART 720G

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Nausea (1970); Pain (1994)

Event Date 06/30/2015

Event Type  Injury  

Event Description

A patient in (b)(6) who first began dialysis on (b)(6) 2015, was undergoing a dialysis session that involved a revaclear 300 dialyzer.Within minutes of initiation of the dialysis treatment the patient became symptomatic with a cough, dyspnea, nausea, and pain in the 3 l of oxygen and administered (b)(6) (methylprednisolone).The patient continued the dialysis treatment as scheduled.

Manufacturer Narrative

The bicart product involved in this incident was discarded and not available for investigation.The device history record for bicart 720g with lot numbers 55050 shows that this lot was produced according to specifications and no similar complaint has been received for this lot number.

• 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: magnus persson ; box 10101; lund ; SW ; 46169000
• MDR Report Key: 4973978
• MDR Text Key: 18638832
• Report Number: 9616023-2015-00013
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K013724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: BICART 720G
• Device Catalogue Number: 109733
• Device Lot Number: 55050
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 55