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

Catalog Number PUMP

Device Problem Inaccurate Delivery (2339)

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.Additional information e1- ext 79247.

Event Description

The event involved a pharm assist dispensing pump on an unspecific date.It was reported the pump was dispensing wrong volume as per end user even after biomed¿s several calibrations.It also had intermittent glitchy display and the unit is 10 years old.There was no report of any patient harm.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17217207
• MDR Text Key: 318024432
• Report Number: 1713468-2023-00001
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 0+$$+75299/16D
• UDI-Public: +$$+75299/16D
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K905116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/05/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED MEDICATION, UNKNOWN MFR