MAUDE Adverse Event Report: MEDISYSTEMS CORPORATION STREAMLINE AIRLESS SYSTEM SET WITH LOCKSITE NEEDLELESS ACCESS SITES AND SECURECL; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number SL-2000M2095L

Device Problems Connection Problem (2900); Output Problem (3005); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2022

Event Type  malfunction  

Event Description

After the patient's ihd was initiated, the machine began alarming due to low transmembrane pressure (tmp), and tmp was in fact outside of appropriate parameters.Upon inspection, it was found that the pressure transducer had a defect, it wasn't patent, had an occlusion that looked as if it was heat-sealed.It could not be fixed, and the entire blood line set had to be discarded.Patient's blood was safely returned.The defect was found in the thin tubing that connects the venous pressure pod to the pressure transducer in the hemodialysis machine.Unfortunately, the line was discarded before the lot number could be captured.Manufacturer response for set, tubing, blood, with and without anti-regurgitation valve, streamline airless system set with locksite needleless access sites and securecl (per site reporter).Pending manufacturer's response.

• Brand Name: STREAMLINE AIRLESS SYSTEM SET WITH LOCKSITE NEEDLELESS ACCESS SITES AND SECURECL
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): MEDISYSTEMS CORPORATION; 350 merrimack st.; lawrence MA 01843
• MDR Report Key: 14753763
• MDR Text Key: 294407798
• Report Number: 14753763
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-2000M2095L
• 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: 05/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Male