MAUDE Adverse Event Report: CARDINAL HEALTH VALVE PULSEWAVE TRUMPET; CATHETER, IRRIGATION

Model Number ASC1201

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

The sample was received for evaluation and has been forwarded to the manufacturing site for evaluation.A follow-up report will be filed when investigation is completed.

Event Description

It was reported that the suction irrigation device leaked from the diaphragm area when the physician was attempting to irrigate intra-abdominally after removal of gallbladder.A second tubing worked, but was not able to increase pressure effectively.

Manufacturer Narrative

We are unable to confirm the issue reported.However, cardinal health has become aware of an issue in which the hydroline and pulse wave trumpet valves may not close properly, which could cause continuous suction.There is a remote possibility that inability to control suction during a procedure may result in loss of carbon dioxide in the abdomen, reduced visibility of the surgical site and potential injury to organs and body tissue.Cardinal health has issued a voluntary recall that was initiated on june 11th 2018.

Manufacturer Narrative

One complaint sample was received for investigation.The pump system was set up with suction system along with 1000ml of saline.Diaphragm was visually inspected for seal prior to use and no cracks were found in the seal.The cassette was attached to pulsewave pump and successfully pumped 1000ml of saline with no leaks.Second valve was set up and functioned well and was able to get up to full pulsewave setting in pumping while pumping 1000ml of saline.Evaluation of the returned complaint sample revealed the issue report could not be confirmed.The device history record(dhr) for the above lot has been reviewed for conformance to the cardinal health specifications.The products are tested 100% for leaks.Specifically the ¿diaphragm¿ is tested for both air leaks and continuity to insure full service when connected to the pulsewave pump.Integrity of diaphragm appears to be in conformance.The product dhr conforms to cardinal health specifications.Testing had been performed prior to final packaging and sterilization and met all requirements.Cassette ¿diaphragm¿ must be properly seated, tubing must be vertically attached to bag, no bends or kinks, pump must be primed before use of any new spike into bag to insure proper flow, pressure and no leaks.

• Brand Name: VALVE PULSEWAVE TRUMPET
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan road; waukegan IL 60085
• MDR Report Key: 7359582
• MDR Text Key: 103414240
• Report Number: 1423537-2018-00170
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10885380107818
• UDI-Public: 10885380107818
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2018

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
• Device Operator: Physician
• Device Model Number: ASC1201
• Device Catalogue Number: ASC1201
• Device Lot Number: 011848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 02/20/2018; 02/20/2018
• Supplement Dates FDA Received: 04/20/2018; 06/28/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other