MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPECTRUM INFUSION PUMP; PUMP, INFUSION

Catalog Number 35700BAX2

Device Problem Volume Accuracy Problem (1675)

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

Event Type  malfunction  

Event Description

It was reported that a spectrum pump failed the delivery accuracy portion of annual preventive maintenance testing in the biomedical service department.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was received for evaluation.During functional testing, pump failed the delivery accuracy was reproduced.Evaluation sent the device for flow accuracy verification testing and the unit was ran for 15 minutes at 40 ml/hr.The vtbi was 10 ml, and 10.901 ml was delivered.The error percentage was 9.01%.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The reported condition was verified.The cause of the condition was determined to be failed upper/lower valve, finger, and pressure plate springs.The upper/lower valve, finger, and pressure plate springs requires replacement to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SPECTRUM INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDINA; 711 park ave; medina NY 14103
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16663121
• MDR Text Key: 312509452
• Report Number: 1314492-2023-01122
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412498683
• UDI-Public: (01)00085412498683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 35700BAX2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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