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

Catalog Number 8713030

Device Problem Pumping Problem (3016)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

As reported by the user facility ((b)(4)) "keypad does not work": the pump started alarming during an infusion, and stopped working.The user was unable to do anything via the pump keypad and unable to remove the syringe from the pump.The infusion was remifentanil, and the pt was intubated.There was a short delay whilst a new remifentanil infusion was set up, and the pt self extubated.[.].

Manufacturer Narrative

(b)(4).The sample has been received for investigation at our service dept in (b)(4) and the investigation is on going at this time.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.The operating unit was already changed.However, the original operating unit was received in addition for investigation.The sample was found heavily contaminated.The device had previously been opened before submitting for investigation, because the cover caps were not available.The history log files showed different device alarms 1113, 1024 and 1105.For the performed long term test, the attached operating unit was mounted to the device.The test revealed no abnormalities nor any device alarms.The perfusor space showed inside several damages caused by fluid as well as the attached operating unit.There we found the contacts to be oxidized.The sample must have been exposed to a heavy amount of fluid out of its specification.Due to the penetrated fluid the device alarmed (1024 and 1105).The result was that the operating unit could not longer operate.In this case the syringe has to be removed from the pump, by the emergency release button.The device was subjected to wrong handling.Following is described in the ifu: · prior to administration, visibly inspect the pump and the accessories (especially the axial fixation) for damage, missing parts or contamination and check audible and visible alarms during selftest.· protect the device and the power supply against moisture.

• Brand Name: PERFUSOR SPACE
• Type of Device: SYRINGE PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen 3421 2; GM 34212
• Manufacturer Contact: ludwig schuetz, safety officer ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4687882
• MDR Text Key: 5639774
• Report Number: 9610825-2015-00119
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2015,03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• 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?: Yes
• Date Returned to Manufacturer: 04/02/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2015
• Distributor Facility Aware Date: 03/19/2015
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2015
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• 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 Outcome(s): Other