MAUDE Adverse Event Report: GAMBRO DASCO S.P.A GAMBRO BLOODLINE ACCESSORIES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number Y CONNECTOR S-660-C

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/01/2016

Event Type  Injury  

Event Description

A patient in the (b)(6) was undergoing a dialysis treatment that included the y connector s-660-c.Twenty minutes into the treatment the patient developed respiratory distress, felt faint, dizziness and nausea.The patient received a bolus of 200 cc nacl and the symptoms decreased after about 40 minutes.The treatment was completed and the extracorporeal blood was returned to the patient.The patient was discharged to home.

• Brand Name: GAMBRO BLOODLINE ACCESSORIES
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): GAMBRO DASCO S.P.A; via modenese 66; medolla I-410 36; IT I-41036
• Manufacturer Contact: via modenese 66; medolla ; 53550111
• MDR Report Key: 5947689
• MDR Text Key: 54627271
• Report Number: 9610270-2016-00001
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K801016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2016

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: Health Professional
• Device Model Number: Y CONNECTOR S-660-C
• Device Catalogue Number: 101354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 69