MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG ACCESSORIES FOR SPACE PUMP; US. POWER CORD INCL. EXTENSION

Catalog Number UNKNOWN

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual sample involved has not been received for evaluation and the investigation is ongoing at this time.A follow up report will be submitted when the investigation results becomes available.

Event Description

As reported by the user facility: medwatch: mw5060216.Event description: rental b.Braun iv pump in use in patient room "sparked".

Manufacturer Narrative

(b)(4).The actual pump involved is not being returned for evaluation.Multiple attempts to obtain the device, logs and or additional information were not successful.Without the actual device or logs, a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.If the device, logs and/ or additional pertinent information becomes available, a follow up report will be submitted.Not returned to manufacturer.

Manufacturer Narrative

(b)(4).Medwatch #mw5060216.(b)(4).Multiple attempts to obtain the device, product code and/or additional information were not successful.Without the device or product code, a thorough investigation could not be performed and further evaluation is not possible.No specific conclusion can be drawn as to the cause of the reported event.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.Additional information: follow up #1 was submitted through the gateway on august 29, 2016 by a b.Braun employee that is no longer with bbraun medical inc.As a result, b.Braun was not able to retrieve the three required acknowledgements indicating successful transmission as the account is password protected.A request was submitted to (b)(6) and (b)(4) was created.Multiple attempts to resolve this issue have not been successful; therefore follow up #2 will serve as the required submission document pending successful retrieval of the three acknowledgements.

• Brand Name: ACCESSORIES FOR SPACE PUMP
• Type of Device: US. POWER CORD INCL. EXTENSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; melsungen, 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5555287
• MDR Text Key: 42161728
• Report Number: 9610825-2016-00195
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2017,03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: UNKNOWN
• 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: 02/15/2017
• Distributor Facility Aware Date: 03/21/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2017
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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