MAUDE Adverse Event Report: RICHARD WOLF GMBH TEM TUBE SET

Model Number 4170.801

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The tube set was requested for testing.The investigation of the device is in progress.A follow-up report will be submitted as soon as the investigation is completed.

Event Description

On (b)(6) 2020, richard wolf (b)(4) (rw (b)(4)) received the following information: the tubing set of the tem single use is not working.It is not possible to create vacuum with the roller pump.The tubing set was replaced during the treatment.The treatment time was delayed by 1 hour.

• Brand Name: TEM TUBE SET
• Type of Device: TEM TUBE SET
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10089628
• MDR Text Key: 204416898
• Report Number: 9611102-2020-00005
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K000180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4170.801
• Device Catalogue Number: 4170.801
• Device Lot Number: 32324159
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other