MAUDE Adverse Event Report: ICU MEDICAL, INC. PHARM ASSIST DISPENSING PUMP; PHARM SYSTEMS&ASSOCIATED DISP

Catalog Number PUMP

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts have been made to the reporter regarding the return of the device for additional testing, however, the manufacturer has been unable to reach the report.In the event that additional information is received, a supplemental report will be issued.

Event Description

It was reported that a pharm assist dispensing pump experienced inaccurate volumes and sporadic accuracy even after device adjustments and re-calibration.The device was reported to be inaccurate by large margins regardless of the liquid used.There was no patient involvement, and no adverse event reported.No additional information is available at this time.

• Brand Name: PHARM ASSIST DISPENSING PUMP
• Type of Device: PHARM SYSTEMS&ASSOCIATED DISP
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• Manufacturer Contact: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10102294
• MDR Text Key: 215369684
• Report Number: 1713468-2020-00002
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Public: +$$+7179631100081/16D
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2020

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
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/29/2020
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1