MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 7300

Device Problem Inaccurate Delivery (2339)

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

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

It was reported that under-infusion occurred during use of the cassette; however, the reporter stated when the patient arrived, there was no medication remaining in the bag.Per the reporter, an alarm occurred and the pump read 9ml.The syringe was primed and the pump was started at 2.2ml/hour with 100ml starting volume.No medication was drawn out and the residual volume was 9ml.Per the reporter, there was no patient injury.

Manufacturer Narrative

Additional information is provided for h.2 and h.6.One sample was received for evaluation.Visual inspection revealed the sample was received in a plastic bag, not its original packaging and in used conditions, without the blue and white cap; no damage or defects were noted.Functional testing was performed, and the reported issue could not be replicated.The root cause could not be determined.Device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.For all enquiries or follow-up questions related to the record, do not use (b)(4) located in sections g.1., please direct those to the following: (b)(4).

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• 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: 18030810
• MDR Text Key: 326864635
• Report Number: 3012307300-2023-10012
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7300
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4381307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1