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

Catalog Number 35700BAX2

Device Problems Protective Measures Problem (3015); Intermittent Loss of Power (4016)

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

Event Type  malfunction  

Event Description

It was reported that a spectrum pump alarmed system error 105 (pic motor error), system error 109 (pic encoder error) and would randomly shut down and restart when infusing medications.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.During functional testing, a system error 105 was reproduced.A system error 109 was not reproduced.A review of the event history log revealed ¿error code 105¿ and ¿error code 109¿.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported events.The reported condition system error 105 was verified.The cause of the condition was determined to be a defective motor.The motor requires replacement to address this issue.The system error 109 was verified; however, the cause was not determined and no pump correction is required.The device is no longer in its received condition and was not evaluated for the symptom ¿pump randomly shut down.¿ the device will be required to pass all testing prior to being returned to the customer.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: 16246231
• MDR Text Key: 308473967
• Report Number: 1314492-2023-00106
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412498683
• UDI-Public: (01)00085412498683
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• 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: 01/04/2023
• Date Manufacturer Received: 01/04/2023
• 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