MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INFUSOMAT®; PUMP, INFUSION

Model Number 8713051U

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Electrolyte Imbalance (2196)

Event Type  malfunction  

Event Description

As reported by the user facility: the pump delivered 200 mg of cisatracurium ( 100 ml ) in 20 minutes.The primary rn stated she programmed the pump, and was double checked by another rn per policy.After 5-10 minutes the air alarm went off and she noted the 100 ml of cisatracurium was infused.

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report (b)(4).The complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device was not returned for evaluation.The log review shows on (b)(6) 2021 and 3:44pm an infusion start of 588ml/hr (concentrate:.022mg/ml; dose rate: 2mcg/kg/min) and 90ml (dl: cisatra).At 3:44pm a pressure alarm occurred with a volume infused to.36ml.At 3:45pm an air alarm occurred with a volume infused to.42ml.At 3:58pm an air alarm occurred with a volume infused to 84.14ml, followed by 4 more air alarms with a total volume infused at 3:59pm of 85.42ml.Based on the results of the investigation the pump operated as intended.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: INFUSOMAT®
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12817299
• MDR Text Key: 282206416
• Report Number: 9610825-2021-00480
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 04046964660887
• UDI-Public: (01)04046964660887
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8713051U
• Device Catalogue Number: 8713051U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1