MAUDE Adverse Event Report: RICHARD WOLF GMBH; TEM PUMP

Model Number	2232644
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility and manufacturer contacted for additional information.Upon receipt of additional information or the completion of the investigation a follow-up report will be submitted.
Event or Problem Description
It was reported: after about 30 minutes during the first case the pump would quit working and the unit would beep.I had to open the trap door and close it to make the beeping go away.Then i would press the tem pump button again to get it to work.This was a temporary fix since it kept faulting more often.It became so bad that my trick didn't work anymore and i had to set up the loaner.Will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.
Additional Manufacturer Narrative
Richard wolf medical instruments (mic) is submitting this report on behalf of richard wolf gmbh.Mic is the importer of this device.The device was visually and functionally evaluated.The reported condition - the pump would quit working and the unit would beep.I had to open the trap door and close it to make the beeping go away.Then i would press the tem pump button again to get it to work - was confirmed.According to our test instruction manual 64600344 pa we found, after 30 minutes the unit stopped and would beep.The pump for the hose is defective.The cause, after eight years operating normally, is normal wear and tear.Rwgmbh considers this case closed.Should additional information become available a follow up report will be submitted.
Event or Problem Description
Please see manufacturers narrative for results of the investigation.

• Brand Name: NA
• Common Device Name: TEM PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10321025
• Report Number: 1418479-2020-00017
• Device Sequence Number: 18981682
• Product Code: HIF
• UDI-Device Identifier: 04055207056462
• UDI-Public: 04055207056462
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021
• 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: Health Professional
• Device Model Number: 2232644
• Device Catalogue Number: 2232.644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAPARO-CO2-PNEU 2232641
• Date Report Sent to FDA: 07/24/2020