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

Model Number 8713112D

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2015

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: the customer reported "broken prongs on charger" however upon receipt of the samples one of the samples exhibited thermal damage.No patient injury.

Manufacturer Narrative

(b)(4).One sample was received and all available information was forwarded to the manufacturer b.Braun melsungen.The outer live pin was bent and thermal damage was found on the power cord.The pins of the power cord that was plugged into the wall may have been in contact with a conductive fluid; also a mechanical damage could not be excluded.The reason for the thermal damage was caused by an electrolysis unleashed by a fluid ingress between the contact of the wall socket and the expected wet conductive pins.Because of the capillary effect the liquid has the ability to get to the conductive parts of the power supply.It should be noted that the instruction 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: 5065147
• MDR Text Key: 25352271
• Report Number: 9610825-2015-00385
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup
• Report Date: 11/03/2015,08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 8713112D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2015
• Distributor Facility Aware Date: 08/28/2015
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2015
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2014
• 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