MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) TEM PUMP

Model Number 2232.644

Device Problem Inflation Problem (1310)

Patient Problem No Information (3190)

Event Date 08/11/2017

Event Type  Injury  

Event Description

Facility reported that during a procedure, system would not inflate enough to fill patients' belly.Doctor opened up patients' abdomen in order to complete the procedure.Manufacture date - 07mar2016, purchase date - 07sep2016, service dates - n/a.No similar events resulting in an mdr has occurred on this device type in the last three years.Facility indicated instruments would be returned for evaluation, not received as of 11sep2017.When instruments are received, they will be sent to manufacturer for evaluation.Facility contacted twice, via email, in order to gather missing/additional information on this event, no response as of 11sep2017.Two instruments work together as one system, a mdr submitted for each device.Tem pump (id #2232.644) - mdr1418479-2017-00020, insufflator (id #2232641) - mdr1418479-2017-00021.Rwmic considers this matter closed.However, in the event rwmic receives additional information, follow-up report will be submitted to fda.

Event Description

Follow up report #1.Richard wolf medical instruments corporation (rwmic) received device on 09/19/2017.Device sent to (b)(4) manufacturer for investigation, no investigation results received as of 02oct2017.

Manufacturer Narrative

Follow up #2, the following was updated/completed: product problem, suspect device, importer (device), corrected/additional data.Richard wolf medical instruments corporation (rwmic) received investigation results from manufacturer on 10oct2017 and added new information to this follow up report.Manufacturer found no issues with device during electrical testing.Pump also tested with an insufflator and no issues were found.Rmic considers this matter closed.However, in the event rwmic receives any additional information a follow report will be submitted to fda.

Event Description

Follow up #2 - manufacturer investigation results.

• Brand Name: TEM PUMP
• Type of Device: TEM PUMP
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6855237
• MDR Text Key: 85645844
• Report Number: 1418479-2017-00020
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04055207056462
• UDI-Public: 04055207056462
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2017,09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 2232.644
• Device Catalogue Number: 2232.644
• 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: 10/17/2017
• Distributor Facility Aware Date: 08/14/2017
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/02/2017; 10/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: INSUFFLATOR
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 93