MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERFUSOR SPACE ; SYRINGE PUMP

Catalog Number 8713030

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

As reported by the user facility ((b)(4)): over infusion: due to a deviation in the continuous blood pressure logging, the personnel thinks that the pump made an unexpected, automatic bolus.

Manufacturer Narrative

(b)(4).The sample has been requested to be returned for eval.A follow up report will be provided when the inspection results become available.(b)(4).

Manufacturer Narrative

(b)(4).Result of examination: the received sample was subjected to a visual and functional examination.No external damages were detected.The device showed age-based marks of use and was found slightly contaminated.The history files were read out and analyzed.According to customer information the incident happened on (b)(4) 2015.On this day no bolus was given by the device.Thereupon a long term test was performed.No malfunction was detected.Further on, the device was dismounted and the inside of the sample was investigated.No damages were found.The pump operated as intended and the reported failure could not be reproduced.No specific conclusion can be made.

• Brand Name: PERFUSOR SPACE
• Type of Device: SYRINGE PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz, safety officer ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4687896
• MDR Text Key: 5693347
• Report Number: 9610825-2015-00121
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K062699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2015,03/31/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 8713030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2015
• Distributor Facility Aware Date: 03/31/2015
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2015
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2015
• 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: Unknown
• Patient Sequence Number: 1