MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM 360 DRIVER INTL ENG; PUMP, INFUSION

Catalog Number 300105405

Device Problem No Flow (2991)

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

Event Date 02/02/2022

Event Type  malfunction  

Event Description

The event involved a plum 360 driver.The customer reported that the pump was not infusing a four-hour chemotherapy treatment of oxaliplatin despite it having correct manual programming.Although the oxaliplatin infusion was checked by two nurses during the afternoon, another nurse checked the pump again and discovered that no infusion had gone through.All of the fluid was left in the container when the issue was noted.There was no alarm of the pump.The time the infusion started was 1130 with a prescribed pump setting of 500ml bag over 4hrs on line a with no filter.The volume of the bag upon the start of the infusion was 500ml bag + the drug.The customer did not report any difficulty in programming or initiating the infusion.There was patient involvement and a delay in therapy.However, there was no medical intervention provided and no report of human harm as a result of the reported event.

Manufacturer Narrative

The device has been received.Investigation is pending.

Manufacturer Narrative

The device was returned for evaluation.No delivery related alarms found in device history.Device history downloaded and maintained.Detailed review period 28 jan 2022 to 28 feb 2022.The logs for this device were reviewed with focus on log entries for week up to stated event date (2 feb 2022).It can be seen for detailed log analysis that no programmed delivers match the customer reported program.The device passed all pvt testing including delivery accuracy testing.As there are no infusions recorded on the device matching the customer¿s programming specifications, and device passed all testing, the customer¿s complaint could not be confirmed.The customer's complaint was not confirmed as not confirmed through logs and not replicated during testing.

• Brand Name: PLUM 360 DRIVER INTL ENG
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13660490
• MDR Text Key: 286661268
• Report Number: 9615050-2022-00040
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Public: +$$+720646898/16D20160317
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300105405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OXALIPLATIN, MFR UNK