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

Model Number 21-7302-24

Device Problems Device Alarm System (1012); Defective Device (2588)

Patient Problems Headache (1880); Hyphema (1911)

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the device malfunctioned.Patient was able to change to an unaffected cassette while on phone with pharmacist.Patient reported that a few weeks ago, patient received an alarm on her pump when setting up a cassette but did not remember what the error message was.Patient switched pumps and now reported both pumps are working fine and it has not happened since.Patient reports experiencing headaches and blood shot eyes.Although the patient presented clinical signs, there is no report of patient injury.It is unknown if the product issue caused or contributed to patient or clinical injury.

Manufacturer Narrative

Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Device evaluation: received samples received consist in 10 cassette products.The samples were received unused, with its original packaging, inside a plastic bag.Visual inspection no damages, kinks or deformities that could cause the failure mode reported were detected.Samples were fully priming and connected without difficult, the pump was set running and no alarms were activated.Failure mode could not be duplicated by functional testing; complaint is not confirmed.Cassette leak testing, install ffp clip and luer capping production performs a 100% in process inspection, to verify for occlusions, kinked tubing, components damaged, verify that the bag is properly placed and verifies that the height of the arch of the pump tube is within specification.Cassette in process testing production performs an accuracy test.Takes a sample of 3 parts at shift start-up, the beginning of every job; at least every 5 hours.Quality procedure for cassette regular, cassette enteral and cassette 250 ml, quality takes a sample of 15 units at an interval of 2 hours, 30 minutes, prior to placing product in bag, to verify for occlusions, kinked tubing and verify that the bag is properly placed and verifies that the height of the arch of the pump tube is within specification.No root cause determine due complaint was not confirmed.No actions taken due complaint was not confirmed.

• Brand Name: CADD CASSETTE RESERVOIRS WITH FLOW STOP
• 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; minneapolis, MN 55442
• MDR Report Key: 16152951
• MDR Text Key: 308419811
• Report Number: 3012307300-2023-00433
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4329615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female