MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA SUCTION PUMP

Model Number 2208011

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Three attempts were made to collect missing information from the user facility.Manufacturer will evaluate device and is responsible for investigation and missing device information.Rwmic considers this case open.A follow up report will be submitted upon receipt of new or additional information.

Event Description

On september 4th and 5th of 2018, the user facility reported the following to richard wolf medical instruments (rwmic): "during a case, the suction was not powerful enough to proceed.They switched out the pumps and everything was fine." will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.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 that put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? yes.

Manufacturer Narrative

Follow up report #1 is to provide fda with new and changed information: the following fields contain new or changed information: a3, b5, f3-5f7, f8, f9, f11, f13,g4, g7, h2, h3,h4, h6, h10.Richard wolf medical instruments corporation (rwmic) considers this case closed.In the event that rwmic receives additional information a follow up report will be submitted to the fda.Caution! for therapeutical use it is necessary to keep an adequate replacement unit at hand should the device fail.Important! run through the checks before and after each use.Do not use products which are damaged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.Check the device and accessories for damaged, loose or missing parts, hygiene and completeness.Check all connection cables and tubes/hoses for damage.Check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces.'check all connection tubes/hoses for damage, hygiene and completeness.'check o--rings and sealing caps as well as insulating parts for perfect condition.Important! in order to carry out the function checks, the devices must be in flawless condition and set up correctly.Carry out a visual check in order to guarantee this condition.Piranha suction pump: the piranha suction pump is equipped with automatic function checks which automatically detect and report their various errors or faults.The errors or faults detected may occur during the self--test or during operation.Switch on the power switch.'after each switch--of the power switch the device runs through an automatic function test (approx.10 seconds).Any fault or error detected is displayed on the lcd display (see section 5.7).'on successful completion of the test, the piranha suction pump is operational.Connect the complete system in accordance with section 3.Richard wolf medical instruments corporation (rwmic) considers this case closed.In the event that rwmic receives additional information a follow up report will be submitted to the fda.

Event Description

User facility returned the device to rwmic on 09/07/2018 and the evaluation was completed on 10/17/2018.The device appeared to be used - the tube set was not connected properly or it was kinked.The reported condition was not verified after using visual and functional testing.It was determined that the outside damages have no influence to the function of the suction pump.After opening the housing it could be determined that the holder for magnetic valve has broken out and the surface of the magnetic valve is damaged.The cause of this damage could not be reconstructed.The root cause was determined to be user handling issues.A manufacturing defect was not identified.

• Brand Name: PIRANHA SUCTION PUMP
• Type of Device: PIRANHA SUCTION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7936814
• MDR Text Key: 125139467
• Report Number: 1418479-2018-00020
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• Combination Product (y/n): N
• PMA/PMN Number: K041610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/12/2019,09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2208011
• Device Catalogue Number: 2208011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2019
• Distributor Facility Aware Date: 09/04/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2019
• Date Manufacturer Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other