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

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was reported that during connection, the pump alarmed completion approximately 11.5 hours early.The pump was programmed at 144 ml at 1.5 ml/hr.When the pump was disconnected, 126.75 ml infused and 17.3 ml remained, however the bag was emptied.No patient injury was reported.

Manufacturer Narrative

Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.D4: model number, catalog number, lot number, expiration date, udi, g5, and h4 are unknown.

Manufacturer Narrative

Other, other text: d3, g1,2 email is: (b)(4).One device was returned for evaluation.Visual inspection revealed no physical damage.Functional testing was performed but the reported issue could not be replicated or confirmed; no discrepancies were detected.The root cause could not be determined.No further action was taken.No lot number was provided; therefore, a history record review could not be conducted.

• Brand Name: CADD ADMINISTRATION SET
• 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: 17999554
• MDR Text Key: 326469114
• Report Number: 3012307300-2023-09852
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/10/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1