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); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2023

Event Type  malfunction  

Event Description

It was reported the disposable caused the pump to exhibit a no disposable pump won't run alarm.No patient injury was reported.

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.

Manufacturer Narrative

Pictures attached: picture 1 show a cassette product from part number 21-7302-24 in used conditions.Picture two show the front view of the cassette product.Picture three show the top view of a cassette product.Pictures 4 show the ay bag neck section from a flow stop cassette model.Sample received: sample received consist in 1 cassette product from part number 21-7302-24.Sample was received after used conditions, without its original packaging, decontaminated and inside plastic bag.Visual inspection: no damages, kinks or cuts were detected in the sample received that could cause the failure mode reported.Functional testing ? first pump: sample was filled with 100 ml of water; the sample was connected a pump and no alarms were activated.Functional testing ? second pump: sample was filled with 100 ml of water; the sample was connected to a second pump and no alarms were activated.Conclusions: failure mode could not be duplicated by functional testing; complaint is not confirmed.- root cause - no root cause determine due complaint was not confirmed.

Manufacturer Narrative

Other, other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.D3, g1,g2 email is: (b)(4).

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16809861
• MDR Text Key: 313951607
• Report Number: 3012307300-2023-04524
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• 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: 4307260
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female