MAUDE Adverse Event Report: B. BRAUN AVITUM AG PERFUSOR®; PUMP, INFUSION

Catalog Number	8713032U
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
It was reported to b.Braun medical inc.That a perfusor® space® syringe pump (material # 8713032u, batch # 97034033f2, serial # (b)(6)) was being used to administer maintenance fluids, specifically d10 at a rate of 80 milliliters per kilogram per day (ml/kg/day).According to the complainant, the patient, a 4-hour-old neonate, diagnosed with respiratory distress syndrome (rds) with transient tachypnea of the newborn (ttn), was being transported via rw transport.During the transport, the syringe pump was positioned beside the isolette on the standard mounting system.No issues were observed prior to placing the infant in the isolette.However, following this transition and while moving to the vehicle, a patient side occlusion alarm activated.The occlusion was identified as a kink in the intravenous (iv) extension arm.The alarm was able to be cleared without issue, and then the pump was successfully restarted.However, following the infusion restart, the pump displayed a total volume to be infused (vtbi) of 0.66ml.Prior to the alarm and restart, the vtbi was noted as being 1.6ml.No further alarms, issues, or discrepancies noted during transport and prior to hand- off.No visible defects were noted with the pump, and it continued functioning properly after resolving the occlusion.The line remained connected to the patient throughout the event, and there was minimal disruption to the infusion.The event resulted in no adverse impact on the patient, as there was minimal delay, and no medical interventions were necessary to mitigate the disruption.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device was not returned for evaluation.Further investigation of the complaint is not possible without a device.If the device does become available, the complaint will be reopened for further evaluation.All information concerning this reported incident has been included in our trend analysis of the product line.

• Brand Name: PERFUSOR®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20683403
• Report Number: 9610825-2024-00835
• Device Sequence Number: 7440556
• Product Code: FRN
• UDI-Device Identifier: 04046964797965
• UDI-Public: (01)04046964797965(11)220712(10)97034033F2
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8713032U
• Device Lot Number: 97034033F2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown