MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS CENTRIFUGAL SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM

Model Number 164267

Device Problems Break (1069); Component Missing (2306); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The fsr replaced the parts (latch, spring and retainer) and all are now operating properly.The unit operated to manufacturer specifications and was returned to clinical use.The suspect parts were returned to the manufacturer, no further action is needed at this time.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, he found all three parts that hold the disposable on to the centrifugal drive motor are broken, cracked, or missing.There was no patient involvement.

• Brand Name: SARNS CENTRIFUGAL SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
• 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: 5682866
• MDR Text Key: 46298250
• Report Number: 1828100-2016-00377
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 164267
• Device Catalogue Number: 164267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/1991
• 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