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

Catalog Number 8713112C

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report has been identified as b.Braun medical internal report number (b)(6).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

The customer is reporting theramal damage.No injuries reported.

Manufacturer Narrative

(b)(4).The provided pictures were examined.According to the pictures the power supply seemed to be in a bad condition and showed heavy marks of use.The male connector of the extension cable was melted down.Assumedly an high amount of fluid caused this thermal damage.Fluid has to be ingressed between the male connector of the extension cable and the female connector of the power supply unit.Based on former tests, this error pattern is a result of usage out of the power supplies specification.If additional pertinent information becomes available, a follow up report will be submitted.

• 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 ; b. braun melsungen ag; carl-braun str. 1; melsungen, 34212 ; GM 34212 ; 661712769
• MDR Report Key: 6048422
• MDR Text Key: 58139774
• Report Number: 9610825-2016-00657
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2016,09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 8713112C
• 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: 12/19/2016
• Distributor Facility Aware Date: 09/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2016
• Date Manufacturer Received: 09/29/2016
• 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