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

Model Number	21-7383-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer contact phone number:(b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that the cadd pump produced an air-in-line alarm while the cadd administration set was in use.The air formed between the puncture mandrel and the pump segment.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Other, other text: h10 ?device evaluation: one cadd administration set was returned for investigation in used condition.The units were visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.Functional testing of the device revealed that there were no issues with priming the device.Additionally, the pump to which the cassettes were attached did not produce any alarms.The product problem reported by the customer was not confirmed.No fault was found with the returned device.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11790241
• Report Number: 3012307300-2021-04010
• Device Sequence Number: 4381177
• Product Code: FPA
• UDI-Device Identifier: 10610586027475
• UDI-Public: 10610586027475
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Other
• Device Model Number: 21-7383-24
• Device Catalogue Number: 21-7383-24
• Device Lot Number: 3971522
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1