MAUDE Adverse Event Report: MEDISYSTEMS CORP STREAMLINE BLOODLINE SET FOR DIALOG; HEMODIALYSIS BLOODLINE SET

Catalog Number SL-2010M2096

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2015

Event Type  Injury  

Event Description

As reported by the user facility: pt complained of burning sensation in neck and nose area.This is event #2 for the same pt as previously reported under mfr report # 2523676-2015-00023 (b)(4).

Manufacturer Narrative

(b)(4).In a follow up with the facility, the event occurred at the start of treatment.The pt was placed into bypass and the symptoms were relieved.The treatment was completed with no additional side effects.The facility reported that no sample is available for eval; however, all available info related to this event has been forwarded to the device mfr, (b)(4), for further investigation.Their investigation is ongoing at this time.A follow up report will be submitted when results of the investigation are available.

• Brand Name: STREAMLINE BLOODLINE SET FOR DIALOG
• Type of Device: HEMODIALYSIS BLOODLINE SET
• Manufacturer (Section D): MEDISYSTEMS CORP; 350 merrimack st; lawrence MA 01843
• Manufacturer Contact: brian conti, assistant mgr ; 350 merrimack st; lawrence, MA 01843 ; 9783328448
• MDR Report Key: 4527345
• MDR Text Key: 5355908
• Report Number: 2523676-2015-00022
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/11/2015,01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SL-2010M2096
• Device Lot Number: 41054010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2015
• Distributor Facility Aware Date: 01/15/2015
• Event Location: Other
• Date Report to Manufacturer: 02/11/2015
• Date Manufacturer Received: 01/15/2015
• 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: Initial
• Patient Sequence Number: 1
• Treatment: 710200L DIALOG A+ DIALYSIS MACHINE
• Patient Outcome(s): Other