MAUDE Adverse Event Report: ICU MEDICAL, INC. PHARM ASSIST DISPENSING PUMP; SET, I.V. FLUID TRANSFER

Catalog Number PUMP

Device Problems Inaccurate Delivery (2339); Environmental Particulates (2930)

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

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Section e: initial reporter phone numbers: (b)(6).

Event Description

The complaint involved a pharm assist dispensing pump that was reportedly improperly filling eclipse balls even though the pump was calibrated.A compounder noticed that the rotor in the front of the pharmassist pump (where the tubing gets inserted) was rubbing with something causing metal particles to fly out from the machine during the daily compounding of eclipse balls.The complainant reported that they have stopped using the pump until they can get a new one due to the inaccuracy concerns and also due to the metal contaminates that are being released.There was no patient involved in the event, and no harm was reported.

Manufacturer Narrative

A complaint investigation was conducted on the pump.The device passed all tests without any issue identified.The device functioned properly without any issue.A 12-month service history review shows no results of the device being returned for repairs or complaints.Visual inspection: pass.Power on test: pass.Keypad test: pass.Operational test: pass.Volume test (3 times): pass.(9.9ml, 9.9ml, 9.9ml, 9.9ml, 10.0ml, 10.0ml, 9.9ml, 9.9ml, 9.9ml, 10.0ml).The unit/pump was opened up for inspection and there was no evidence of internal damage identified.The reported complaint of inaccuracy and metal shavings leaving the machine was not confirmed.The device passed all tests without any issue being found.The device was found to be accurate and no metal shavings were found during testing.

• Brand Name: PHARM ASSIST DISPENSING PUMP
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17975686
• MDR Text Key: 326503870
• Report Number: 1713468-2023-00002
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Public: +$$+7179631300051/16D20170331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PUMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED ECLIPSE MEDICINE BALLS, MFR UNK.