MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-23 for RESQPUMP 12-0823-000 manufactured by Advanced Circulatory Systems.
[83435085]
After removing the resqpump from the box, the pump was in good condition with no signs of damage. The force gauge was zeroed when first removed from the box. When the pump was compressed for the first time, it got stuck at 50 kg. After taking the clamshell apart, the gauge mechanism visually looked to be in working order (spring and gauge in correct orientation). The pushrod stem could be pulled out but was difficult to do the first time. A black spot was identified on stem that was potentially excess loctite but it wasn't confirmed. When the pump was reassembled, the gauge worked smoothly and no other problems were detected. The accuracy of the force gauge was verified on a scale and are within specification. The investigation suggests that an excessive amount of loctite was put on the stem causing it to stick in place. This caused the force gauge to get stuck at 50 kg after being compressed.
Patient Sequence No: 1, Text Type: N, H10
[83435086]
Unwrapped the resqpumps straight from the box. The force gauge on one of the pumps was stuck at 50.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2017-00005 |
| MDR Report Key | 6813958 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-23 |
| Date of Report | 2017-08-23 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-07-18 |
| Date Added to Maude | 2017-08-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. DIANE HOWELL |
| Manufacturer Street | 1905 COUNTY ROAD C WEST |
| Manufacturer City | ROSEVILLE MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6514035600 |
| Manufacturer G1 | SCIENTIFIC MOLDING CORPORATION |
| Manufacturer Street | 330 SMC DRIVE |
| Manufacturer City | SOMERSET WI 54025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESQPUMP |
| Generic Name | RESQPUMP |
| Product Code | PIZ |
| Date Received | 2017-08-23 |
| Returned To Mfg | 2017-07-31 |
| Model Number | 12-0823-000 |
| Lot Number | 51733641 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED CIRCULATORY SYSTEMS |
| Manufacturer Address | 1905 COUNTY ROAD C WEST ROSEVILLE MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-23 |