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

Model Number 21-7308-24

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Underdose (2542)

Event Date 08/25/2020

Event Type  malfunction  

Event Description

It was reported that the device was in use for infusion of blinatumomab (immunotherapy) at a rate of 2.5 ml/hr for 96 hours.The reporter stated at the end of scheduled infusion approximately 20-25% of the medication remained in the cassette.The reporter stated the patient will be hospitalized for the next 2 cycles of therapy to ensure therapy is administered properly (10 days).No further adverse effects reported.

Manufacturer Narrative

Other, other text: device evaluation- one used device and one unused device was returned for evaluation.The devices were given delivery testing: this showed the devices both met with specifications.The reported issue was not confirmed.

• 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
• MDR Report Key: 10556894
• MDR Text Key: 207689549
• Report Number: 3012307300-2020-09546
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21-7308-24
• Device Catalogue Number: 21-7308-24
• Device Lot Number: 3743615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 106