MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEDINA SPECTRUM INFUSION PUMP

Catalog Number 35700BAX

Device Problem Low Battery (2584)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation at this time.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a spectrum pump experienced a very low battery alert.There was no patient involvement associated with this event.No additional information is available.

Manufacturer Narrative

The device was received and evaluation was completed.The event history log review was completed and it noted the presence of this alarm in the log.A visual inspection was performed and no abnormalities were found.The reported issue could be reproduced during the device evaluation.The device was determined to not meet all product specifications related to the reported event.The very low battery was verified.The cause was determined to be a damaged ac power adapter which was replaced to correct this condition.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SPECTRUM INFUSION PUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): BAXTER HEALTHCARE - MEDINA; medina NY
• 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: 7439766
• MDR Text Key: 105906275
• Report Number: 1314492-2018-01281
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• PMA/PMN Number: K042121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 35700BAX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2018
• 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