MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIRS - FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7310-24
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Insufficient Information (4580)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the disposable was in use by two separate patients, both using a separate devices programmed for pca use.They had no similar issues prior to the use of this lot number.The disposables in question were compounded on different days and quantity of fluid added to the reservoir has been verified to be correct by multiple pharmacists on their staff.These reservoirs ran empty despite showing anywhere between 24.7ml - 56ml remaining in the reservoir.Device programming and overall use verified using the device report features.They are quarantining the specific lot for a long time being.250 cadd reservoirs run out early on patients.
Additional Manufacturer Narrative
Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture., corrected data: h6: health effects - clinical signs and symptoms or conditions:.

• Brand Name: CADD CASSETTE RESERVOIRS - FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16914630
• Report Number: 3012307300-2023-05598
• Device Sequence Number: 12356434
• Product Code: FPA
• UDI-Device Identifier: 10610586032394
• UDI-Public: 10610586032394
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K081156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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: Other
• Device Model Number: 21-7310-24
• Device Catalogue Number: 21-7310-24
• Device Lot Number: 4354512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic