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 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a spectrum pump experienced a low battery alarm.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Baxter received and evaluated the device.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition low battery was verified.The device was found out of specification in relation to the reported low battery alarms which were reproduced during evaluation.The power cord was replaced to correct this condition.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

N/a.

• 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: 7538703
• MDR Text Key: 109101382
• Report Number: 1314492-2018-01750
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412091570
• UDI-Public: (01)00085412091570
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• 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: 06/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2018
• 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