MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIR NON-FLOW STOP; RESERVOIR, CASSETTE

Catalog Number 21-7002-24

Device Problems Device Alarm System (1012); Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)

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

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

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 device to alarm and deliver infusion two hours early.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other text: d4, d10.Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: one sample was received in unused condition.During the visual inspection, no damage was found.During the functional testing, the cassette was set up to be used with a pump.The fluid was able to flow through the whole device and no alarms were activated.The customer reported fault was unable to be confirmed.A root cause was unable to be confirmed.There were no relevant findings detected in the dhr.

• Brand Name: CADD CASSETTE RESERVOIR NON-FLOW STOP
• Type of Device: RESERVOIR, CASSETTE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16903557
• MDR Text Key: 314921710
• Report Number: 3012307300-2023-05483
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K843772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7002-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 07/22/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1