MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIRS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7301-24

Device Problems Device Alarm System (1012); Product Quality Problem (1506)

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the disposable caused the pump to alarm no disposable, clamp tubing".The patient started using the cassette on apr/13.Then, on apr/17, a "no disposable, clamp tubing" alarm went off.The patient detached the cassette, raised the tubing position slightly, and attached the cassette to the pump again.After that, the alarm was settled.No patient injury reported.

Manufacturer Narrative

Other, other text: device evaluated, picture one shows cassette product out of its original packaging.Picture two shows the front view of a cassette.Picture three shows the top view of cassette.Picture four shows the pressure plate latch section of the cassette.Visual inspection showed the sample was received without the blue clip.No damages, kinks, cuts or any other damage detected.Functional testing performed and the failure mode could not be duplicated by functional testing, complaint is not confirmed.No root cause determined due to complaint was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD CASSETTE RESERVOIRS WITH FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16831430
• MDR Text Key: 314169547
• Report Number: 3012307300-2023-04713
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027215
• UDI-Public: 10610586027215
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7301-24
• Device Catalogue Number: 21-7301-24
• Device Lot Number: 4354548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1