MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 PERFUSION SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS ROLLER PUMP

Model Number 16402

Device Problems Material Rupture (1546); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) has not performed preventive maintenance (pm) on this unit in over 14 months.Per follow-up with the fsr on (b)(6) 2015: the fsr pm¿d the 8k perfusion system the previous night.The fsr found nothing that was out of specification during the entire pm, the system and pump turned out be a normal pm.One of the ccps that was there yesterday told me it was ¿something they did¿ during case, and had nothing to do with the roller pump performance.The fsr installed new pm parts and completed most of the pm.The fsr then returned a second day and greased all occluder knobs and installed new snap rings for the roller pumps.The fsr completed all service successfully.The unit operated to manufacturer specifications and was returned to clinical use.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the tubing ruptured inside the roller pump's raceway (pump #2) while being in use.The device was not changed out.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was confirmed.Based on the limited information available no definitive cause can be determined, though the field service representative (fsr) has confirmed that there is no product deficiency of the 8k pump.No additional action will be taken at this time.

Manufacturer Narrative

The investigator has informed medtronic of the reported issue.

• Brand Name: SARNS 8000 PERFUSION SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS ROLLER PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5081648
• MDR Text Key: 26035626
• Report Number: 1828100-2015-00794
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1