MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL

Model Number 16402

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.Per the user facility's bmet, the cable had been strained too far and broke some of the connections between the pump and the cardioplegia cable.During testing the pump would not stop when the cardioplegia monitor would alarm as a result.The unit is currently not in use.

Event Description

The biomedical technician (bmet) reported that during preventive maintenance (pm) of the device, the cardioplegia cable was defective.There was no patient involvement.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) connected the roller pump to a heart lung machine (hlm) and created an alarm from the cardioplegia (cpg) monitor and the pump responded appropriately by stopping.The user facility's cpg cable was not returned so no testing could be completed on the cable.

Manufacturer Narrative

The reported complaint could not be confirmed.Per the user facility, the pump cable that is within question is not used on the pump, therefore, was not returned for evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: SARNS 8000 UNIVERSAL ROLLER PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7823796
• MDR Text Key: 118552203
• Report Number: 1828100-2018-00445
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K953901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1