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

Catalog Number 8713030U

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the device involved in the reported incident was not returned for evaluation, the device history logs were provided by the user facility for evaluation.Based on the log review it was determined that during the course of the infusion the pump alarmed multiple times for pressure alarms.These alarms are caused by blocked iv lines or by a blocked iv access, and until the iv is cleared the pump is not able to deliver medication to the patient.As a result the time it would take to infuse the full dose would be impacted.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.Based on the results of the investigation, the pump operated as intended.If additional information becomes available, a follow up report will be submitted.

Event Description

As reported by user facility: morphine 10 mg/20 ml in a 35 ml monoject syringe was running on the pump at.33 ml/hr.At the end of the shift, the nurse caring for the patient noted that there should have been 12.73 ml remaining in the syringe but that there was actually 17 ml remaining.

• Brand Name: PERFUSOR®
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4842408332
• MDR Report Key: 8290699
• MDR Text Key: 134597130
• Report Number: 9610825-2019-00003
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8713030U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2019
• Distributor Facility Aware Date: 01/14/2019
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2019
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2012
• 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
• Patient Age: 2 MO
• Patient Weight: 4