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

Catalog Number 8713112C

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual sample involved has been received for evaluation and the investigation is ongoing at this time.A follow up report will be submitted when the investigation results become available.

Event Description

As reported by the user facility: thermal damage to power cord.No patient injury.

Manufacturer Narrative

(b)(4).One sample was received and all available information was forwarded to the manufacturer b.Braun (b)(4).The samples were in a dirty condition.A thermal damage and traces of soot could be found at the connection between the power supply and the power cord.Fluid residue could be found on the connection clip, under the mounting clip, in the p2 connector and the housing.The cable was damaged behind the p2 connector.The connection clips of the power supply have a crack in the material.Thermal damage was also noted at the c-7 connector and c8 plug.The reason for the thermal damage is fluid ingress.Because of the capillary effect the liquid has the ability to get to the conductive parts of the power supply.Previous test in the past have shown that damages of this nature are the result of fluid ingress between the connection of the primary adaptor and the power supply itself.It should be noted that the instructions for use (ifu) for the space pump state "protect the device and the power supply from moisture" and iso symbol to protect from moisture is displayed on the power supply.

• Brand Name: ACCESSORIES FOR SPACE PUMPS
• 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, D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 5021462
• MDR Text Key: 24674988
• Report Number: 9610825-2015-00351
• 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,user faci
• Reporter Occupation: Health Professional
• Report Date: 09/25/2015,08/13/2015

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: 8713112C
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2015
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1