MAUDE Adverse Event Report: MEDISYSTEM STREAMLINE CORPORATION / B. BRAUN MEDICAL INC. MEDISYSTEM STREAMLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number SL-2000M2095L

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Code Available (3191)

Event Date 09/09/2019

Event Type  malfunction  

Event Description

Disposable dialysis blood lines were found to have "pin hole blood leak" upon initiation of dialysis treatment.Dialysis treatment was ongoing for approx 30 secs when blood leak was noted.Dialysis treatment was stopped and no rinse back was given.Pt loss approx 25 ml of blood.Pt alert and oriented.All vitals stable dr (b)(6) was made aware of blood loss due to "pin hole".Dialysis disposable lines were changed and treatment restarted without difficulty.Did not order any lab work due to minimal blood loss and pt stable.Dialysis mgr made aware of defective line.The blood line was placed in a red plastic bag and saved for further evidence if required.Dialysis mgr to contact medisystem streamline corporation to inform them of defective blood line.Lot #90455026, ref sl-2000m2095l.Expiration date: 04/03/2022.Fda safety report id# (b)(4).

• Brand Name: MEDISYSTEM STREAMLINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): MEDISYSTEM STREAMLINE CORPORATION / B. BRAUN MEDICAL INC.
• MDR Report Key: 9105971
• MDR Text Key: 159837572
• Report Number: MW5089965
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: SL-2000M2095L
• Device Catalogue Number: SL-2000M2095L
• Device Lot Number: 90455026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other