MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-02 for RESQPUMP 12-0823-000 manufactured by Advanced Circulatory Systems.
[76623002]
The pump arrived at acsi with the force gauge reading at 40 kg. The gauge would not move during attempting to compress or decompress the pump. Nothing external or internal indicated that there were any modifications or misuse of the device. The pushrod assembly was stuck in the transfer spring. It took a good amount of force to manually remove the pushrod. The pushrod loosened up after some manipulation. The components were reassembled and the force gauge returned to zero. The force gauge was verified on a scale (force gauge kg/scale kg; -15/-14, 50/54) all within specification. The gauge returned to zero after each compression/decompression. It is thought that excess loctite was on the pushrod stem. When the pump was compressed, the pushrod must have gotten stuck in the up position causing the gauge to read high and not return to zero.
Patient Sequence No: 1, Text Type: N, H10
[76623003]
The resqpump force gauge was reported stuck in the compression range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2017-00002 |
| MDR Report Key | 6609818 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-02 |
| Date of Event | 2017-05-08 |
| Date Mfgr Received | 2017-05-08 |
| Device Manufacturer Date | 2016-01-11 |
| Date Added to Maude | 2017-06-02 |
| 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 | MS DIANE HOWELL |
| Manufacturer Street | 1905 COUNTY RD C WEST |
| Manufacturer City | ROSEVILLE MN 55426 |
| Manufacturer Country | US |
| Manufacturer Postal | 55426 |
| 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 | 2017-06-02 |
| Returned To Mfg | 2017-05-10 |
| Model Number | 12-0823-000 |
| 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 RD C WEST ROSEVILLE MN 55426 US 55426 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-02 |