MAUDE Adverse Event Report: ST PAUL CADD-SOLIS ADMININSTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7040-24
Medical Device Problem Codes	Device Alarm System (1012); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No lot number was provided; therefore, device history record review could not be completed.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.A sample of 32 units was taken in order to verify that all bonds were properly bonded; no discrepancies were found.A product sample was received for evaluation and was forwarded to the supplier for exhaustive analysis.During incoming inspection, no damage or anomalies were observed on the sets.The sample sets were subject to leakage testing, during which no leakage was observed in either set.The root cause of the reported issue was unable to be determined.Actions were taken to mitigate the reported issue: a corrective and preventative action has been opened to address the reported issue.
Event or Problem Description
It was reported that the device was leaking and also showing downstream occlusion alarm.No patient injury was reported.

• Brand Name: CADD-SOLIS ADMININSTRATION SETS
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15695009
• Report Number: 3012307300-2022-26489
• Device Sequence Number: 15153696
• Product Code: FPA
• UDI-Device Identifier: 10610586020223
• UDI-Public: 10610586020223
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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: Health Professional
• Device Model Number: 21-7040-24
• Device Catalogue Number: 21-7040-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 34 YR
• Patient Sex: Female
• Patient Weight: 61 KG