MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for 3M? RANGER? HIGH FLOW DISPOSABLE SET N/A 24355 manufactured by 3m Health Care.
[187708063]
Patient information: no information was provided. The sample was evaluated. Sample evaluation showed a leak in the drip chamber due to a solvent bond failure. Corrective action was issued to address solvent bond leaks. Lot hx8341 was produced post corrective action implementation. 3m will continue to monitor.
Patient Sequence No: 1, Text Type: N, H10
[187708064]
A hospital employee reported that a 3m? Ranger? High flow disposable set (model 24355) was primed with normal saline and loaded into a ranger? Rapid pressure infuser during an mtp procedure on (b)(6) 2020. The employee alleged that upon initiation of the pressure infuser, blood started to leak around the filter chamber and over the floor. The flow rate at the time was high. The employee reported that the active bleeding patient needed a massive transfusion and care was delayed. The tubing reportedly was switched, a new set was primed, and the mtp was restarted. No harmful exposure to blood was specified. No patient or staff injury was specified. There were reportedly no issues with the disposable set during priming. The patient's current condition is unknown. The ranger? Pressure infusor was sent to the facility's biomed for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00015 |
| MDR Report Key | 9823903 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-03-05 |
| Date Added to Maude | 2020-03-12 |
| 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. DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 7379117 |
| Manufacturer G1 | NYPRO PRECISION ASSEMBLIES |
| Manufacturer Street | SOR JUANA INES DE LA CRUZ CD. INDUSTRIAL |
| Manufacturer City | TIJUANA, 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? RANGER? HIGH FLOW DISPOSABLE SET |
| Generic Name | HIGH FLOW DISPOSABLE TUBING |
| Product Code | BSB |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-02-24 |
| Model Number | N/A |
| Catalog Number | 24355 |
| Lot Number | HX8341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |