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); Inaccurate Delivery (2339)

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

Event Date 12/20/2022

Event Type  malfunction  

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.

Event Description

It was reported the disposable caused the pump to alarm ? no cassette".The night shift nurse took the disposable off and put it on again and the pump started to alarm again.When the disposable was removed from the pump, there was 33,7 ml of medicine left, that went to waste.? no adverse patient effects were reported by the customer".

Manufacturer Narrative

Other text: d10.Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: one sample was received in used condition.A visual inspection found that the sample was received without the white cap but no other damage was noted.During the functional testing, the sample was filled with water and attached to a pump.The sample was fully priming and connected to the pump with no difficulty.The pump was running with no alarms activated.The customer complaint was unable to be confirmed.A root cause was not established.A batch review was conducted to the lot number reported, the results concluded in no deviations and non-conformances were open during the manufacture of this lot related to the issue reported.By the date of this complaint investigation report no more complaints related to the failure mode and lot number reported in the last 12 months.

• 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: 16903176
• MDR Text Key: 314921522
• Report Number: 3012307300-2023-05476
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4294025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic
• Patient Race: White