MAUDE Adverse Event Report: ICU MEDICAL, INC. PHARM ASSIST DISPENSING PUMP; PHARMASSIST

Catalog Number PUMP

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Patient Involvement (2645)

Event Date 01/02/2020

Event Type  malfunction  

Manufacturer Narrative

The involved pharmassist pump was returned on 01/29/2020.Investigation and analysis have not yet begun.As additional information is received, a supplemental report will be submitted.

Event Description

Complaint received reporting pharma assist pump was making ¿a noise¿ when it is running, was not pumping the correct amount, and makes the ¿tubing leak¿.This was reportedly occurring after calibration.There was no patient involvement, no delay in therapy.

Manufacturer Narrative

H10: the device ran through the volume test (accuracy test) three times without any issue.Three additional volume test at 200ml was performed no issues were noted.The results of the three additional tests are within 1% of the stated discrepancy limit.The reported accuracy issue could not be confirmed.The device passed all functional tests and accuracy tests without any issue being noticed.A 12-month service history review shows no results of the device being returned for repairs or complaints.

• Brand Name: PHARM ASSIST DISPENSING PUMP
• Type of Device: PHARMASSIST
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 9653055
• MDR Text Key: 195533475
• Report Number: 2025816-2020-00001
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Public: +$$+71958090290016/16D
• Combination Product (y/n): N
• PMA/PMN Number: K905116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

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?: Yes
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1