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

Model Number	21-7355-24
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a pump was scheduled to be disconnected from the cadd administration set that was infusing doxorubici, dacarbazine, infusion for 24 hours over three days, however it was observed the bag still had an estimated 35 to 40 ml of the drug remaining.It was reported upon further inspection of the pump and volume readings the pump indicated 720 ml had been infused at 240 ml over three days.No adverse patient effects were reported.No additional information is available at this time.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 1mc11.2339; minneapolis, MN 55442
• MDR Report Key: 12954037
• Report Number: 3012307300-2021-12388
• Device Sequence Number: 14532208
• Product Code: FPA
• UDI-Device Identifier: 10610586027376
• UDI-Public: 10610586027376
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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
• Device Model Number: 21-7355-24
• Device Catalogue Number: 21-7355-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown