MAUDE Adverse Event Report: RICHARD WOLF GMBH TEM PUMP; TEM PUMP,

Model Number	2232.644
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility will be contacted for additional information.Additionally, a follow up will be provided upon completion of the manufacturer investigation.
Event or Problem Description
On (b)(6) 2020, richard wolf medical instruments corp.(rwmic) received the following information: first time the customer has used both items since they came in for repair in (b)(6) 2019.During the procedure, pump stopped working and error code e37 showed up on screen and then the red triangle started to flash.Procedure was still being done when customer called this in, but it was later learned that the procedure was not completed due to the item going down.A back up device was not available for use.There was no injury to patient reported.
Event or Problem Description
User facility returned the device to rwmic on 01/24/2020 and rwmic send the device to the manufacturer for evalotion on 02/07/2020.Rwmic also reached out to the inital reporter to request additional information but no further information could be provided.
Additional Manufacturer Narrative
Follow up report 1 is to provide fda with missing information, new information and/or changed information: user facility was contacted in an effort to collect patient information and user information.However, the initial reporter could not provide any additional information.The manufacturer evaluated the device and the following information were provided in the report: the device was visually inspected and appeared to be used.Functional, electrical and endurance test was performed but no error could be detected.Per manufacturer, the reported condition could not be confirmed and the device meets the specifications.The probable root cause was determined to be the user error.At this time, rwmic considers this case closed.If additional or new information become available, a follow up report will be submitted.

• Brand Name: TEM PUMP
• Common Device Name: TEM PUMP,
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 9682543
• Report Number: 1418479-2020-00003
• Device Sequence Number: 2800653
• Product Code: HIF
• UDI-Device Identifier: 04055207056462
• UDI-Public: 04055207056462
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K000180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section F): 07/24/2020

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
• Operator of Device: No Information
• Device Model Number: 2232.644
• Device Catalogue Number: 2232.644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/08/2020
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 07/24/2020