MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. SPLIT STREAM

Model Number UNK SPLIT STREAM

Device Problem Disconnection (1171)

Patient Problem Distress (2329)

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.We are currently waiting for the sample to be returned for evaluation.We were told that due to holidays in the eu, the device will not be sent until september 12, 2022.When the investigation is complete a final report will be submitted.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After 3 hours of dialysis, there was an arterial pressure alarm.Then it was seen that thetegoconnector and the white intermediate section from the catheter, got disconnected from the patient.The arterial clamp was open, causing some panic for a possible air embolism.The patient's parameters were examined and the patient was placed in trendelenburg position.A nurse renewed the entire arterial line while other nurses set the analyzer in circulation mode, as to prevent coagulation.The doctor examined the patient and beside the patient's slow reaction, there were no medical particularities.

Manufacturer Narrative

One arterial adapter was returned for evaluation.Visual inspection revealed no obvious defects with the device.The side grips show signs of the device being held with hemostat to either tighten or loosen the luer connection.All relative measurements were taken and found the returned device is within specification.A syringe was connected to the luer and hand tightened.Both devices were then pulled in an attempt to disconnect but the connection remained intact.No failure was noted with the returned device.The lot number was not provided.Without a lot number a review of the manufacture records is not possible.A root cause cannot be determined.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SPLIT STREAM
• Type of Device: SPLIT STREAM
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 15294804
• MDR Text Key: 303260238
• Report Number: 2518902-2022-00051
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNK SPLIT STREAM
• Device Catalogue Number: UNK SPLIT STREAM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 86 KG