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

Lot Number 4076288

Device Problem Failure to Deliver (2338)

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

Event Date 05/14/2021

Event Type  malfunction  

Event Description

It was reported that a patient's cassette was changed on a friday and used for the weekend.On monday, the pump displayed that there were 18ml's remaining, so the nurse went back out to change the cassette again but to her surprise the cassette was still full.The nurse measured it when she took it off to waste the remainder so apparently the patient got no medication all weekend.There were no alarms according to the family.The clinician threw it away.The only medical intervention was monday when i got a call from the nurse there to change the cassette saying that the cassette (from friday) was still full.At the concentration and dose delivered, the patient would have gotten 0.25ml/hr (at least 18ml over 72hrs), more with bolusing.This is a hospice patient, and the medication was for palliative pain relief.

Manufacturer Narrative

Other, other text: d4 and g5 were unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A sample was received in used conditions inside a plastic bag, without its original packaging and decontaminated.The sample was visually inspected at a distance of 12in to 16in under normal conditions of illumination to detect samples conditions that could cause functional issues.The sample did not present any damage, scuffs, pinch marks, cracks, crazing, etc.Which could cause the failure mode reported.The sample was connected to the pump and a balance mettler toledo to look for unusual function.The sample was fully priming and connected without difficulty.The pump was set running and no alarms were activated.The complaint was not confirmed.No root cause could be determined, and no actions were taken due to complaint was not confirmed.The delivery accuracy test was passed.

• Brand Name: CADD CASSETTE RESERVOIRS
• 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: 17009404
• MDR Text Key: 315999185
• Report Number: 3012307300-2023-05689
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4076288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1