Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20973 |
| Brand Name: | TCVS Heart lung machine |
| Model: | |
| Affected: | Base for Terumo Advanced Perfusion System 1 |
| Software version: | |
| Recalling Organisation: | Terumo Australia Pty Ltd (NZ) c/- Healthcare Logistics 56 Carrington Road Mount Albert Auckland 1025 |
| Contact Information: | 0800 66 77 57 |
| Manufacturer: | Terumo Cardiovascular Systems Corp |
| Issue: | The manufacturer has received reports of instances in which the 6 Roller Pump for the Terumo Advanced Perfusion System 1 displayed a pump jam message and stopped while in use. Investigation concluded that, while there is no specific evidence that the 6 roller pumps were operating outside manufacturing specifications: 1. Pump jam is more likely to occur when using the 6 roller pump for low-RPM cardioplegia delivery than when using the 4 roller pump for dual-sized tube set cardioplegia delivery. 2. The occlusion settings suggested in the Operator's Manual for some dual-sized tubing sets may increase the likelihood of pump jam on the 6 roller pump. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/12/2016 |
