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

Model Number 7300

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Date 01/04/2021

Event Type  malfunction  

Event Description

It was reported that a smiths medical pump displayed no disposable alarm.No adverse patient effects were reported.

Manufacturer Narrative

H3: two cadd cassette reservoirs from part number 21-7308-24, lot number 3955135 were received in new condition inside their closed original packaging.The samples were filled using a syringe then connected to the a cadd legacy pump; the sample was primed and connected without difficult.The pump was set running and no alarm was activated.The failure was not confirmed because the returned samples passed the functional test.There was no fault found with the returned samples.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11277340
• MDR Text Key: 230213769
• Report Number: 3012307300-2021-00814
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586032370
• UDI-Public: 10610586032370
• Combination Product (y/n): N
• PMA/PMN Number: K081156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7300
• Device Catalogue Number: 21-7308-24
• Device Lot Number: 3955135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1