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

Model Number 21-7302-24

Device Problem False Alarm (1013)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

Report source: (b)(6).Adverse event: hospitalization (initial or prolonged).

Event Description

Information was received indicating that during use of the cassette the pump exhibited a "no disposable, pump won't run" alarm and a "no message" alarm.It was reported that the alarms could not be cleared and that subsequently the patient was transported to the hospital to get medical treatment.Per reporter the cassette was used with a cadd-legacy plus pump.

Manufacturer Narrative

Other, other text: h6: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The device appeared to be in good physical condition.The medication bag contained a substance and the device was missing the blue clip.Upon function testing the reported problem could not be duplicated.The root cause of the reported problem could not be determined as the device functioned appropriately.A manufacturing device history record review was not performed because no lot number was provided.

• Brand Name: CADD MEDICATION CASSETTE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14462348
• MDR Text Key: 292468703
• Report Number: 3012307300-2022-09305
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic