MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7047-24

Device Problems Excess Flow or Over-Infusion (1311); Product Quality Problem (1506); 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: d10.Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: one sample was received.The visual inspection found no damage.During the functional testing, the sample was connected to a filled cassette and a pump.The pump was set to run and no alarms were activated.The customer reported failure was not confirmed.A root cause was unable to be confirmed.There was no non-conformance or deviation related to the failure reported in the device history record for finish good and component associated.By the date of this complaint investigation report no complaint related to the failure mode and lot number reported in the last 12 months.

• Brand Name: CADD EXTENSION SETS
• 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: 16902840
• MDR Text Key: 314912818
• Report Number: 3012307300-2023-05466
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020315
• UDI-Public: 10610586020315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942046
• 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: 08/04/2023

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 Model Number: 21-7047-24
• Device Catalogue Number: 21-7047-24
• Device Lot Number: 4354707
• 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: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1