MAUDE Adverse Event Report: NULL; PUMP, INFUSION

Catalog Number 21-6300-09

Device Problem Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2023

Event Type  Death  

Manufacturer Narrative

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 pump under delivered.After filling up 250 ml of 1% oxycodone medical fluid into the cassette, the disposable (a pharmacy staff) started administration to the patient on (b)(6) 2019, with the flow rate of 0.5 ml/hr.The disposable was used until mar/30.Then, the customer was informed that there was a discrepancy in the remaining amount (an under delivery), and the customer changed the disposable to another new one.At that time, the remaining volume displayed on the screen was 14 ml, the effective dose count 200, the dose count 288, and the administered (infused) volume being 235 ml.However, when the customer checked the disposable at the pharmacy, the actual remaining volume was 52 ml.The physician commented that the cause of death was due to the patient's primary illness, and not due to the defect in the product.

Manufacturer Narrative

No serial number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.

• Type of Device: PUMP, INFUSION
• Manufacturer (Section G): NULL
• MDR Report Key: 16830123
• MDR Text Key: 314153773
• Report Number: 3012307300-2023-04682
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-6300-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death