MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-04-13 for PNEUPAC? SINGLE USE PATIENT CIRCUIT 100/905/300 manufactured by Smiths Medical Asd, Inc..
[72754366]
Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[72754367]
It was reported that a pneupac? Single use patient circuit patient ventilation valve was not connected to the tubing upon opening. Preceding the device issue, the patient had collapsed and the emergency treatment staff was called. Upon arrival, the patient was found to be in cardiac arrest with pulseless electrical activity. The user initiated bag valve mask (bvm) ventilation, then inserted an igel airway. Once this airway was established, the user then attempted to place patient on ventilator care using the patient circuit. It was reported the circuit was missing the patient valve (peep valve) and the user connected the incorrect end of the circuit on the catheter mount. It was observed that the translucent fitting was not in the bag. The user switched back to bvm ventilation because the ventilation wasn't working. During treatment, the patient's status moved from in asystole to ventricular fibrillation shock x 1 to asystole. The patient's daughter requested that the resuscitation be terminated after approximately 30 minutes due to asystole and poor prognosis. User reported that the patient's history showed an 8cm abdominal aneurysm. The cause of death is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
[74180741]
Patient Sequence No: 1, Text Type: N, H10
[74180742]
It was previously reported that the circuit was missing the patient valve (peep valve) and the user connected the incorrect end of the circuit on the catheter mount. Reporter has since clarified with smiths medical that the patient valve was missing (no peep valve involved) and the tubing was connected to the catheter mount (missing patient valve not noted during connection process). Reporter stated the issue with the patient valve was noted after 2 minutes of ventilation of patient. At that time the patient was switched back to bvm ventilation as noted above. Reporter stated that the checks performed during this time "revealed the patient was ventilated" however the missing patient valve had an effect of "increased dead air space". Reporter was unable to confirm cause of patient death.
Patient Sequence No: 1, Text Type: D, B5
[81848938]
One device was returned for evaluation. Visual inspection of the device found that the straight connector was missing from the patient circuit. It was unable to be determined if the device was caused by an external force. A review of the shipping and process controls was performed and conformed to requirements. Based on the evidence, the root cause of the issue was unable to be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-00855 |
| MDR Report Key | 6491284 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-04-13 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-03-20 |
| Date Mfgr Received | 2017-07-14 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2017-04-13 |
| 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 | LISA PERZ |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 9124 POLK LANE SUITE 101 |
| Manufacturer City | OLIVE BRANCH MS 38654 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38654 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNEUPAC? SINGLE USE PATIENT CIRCUIT |
| Generic Name | ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE |
| Product Code | BYE |
| Date Received | 2017-04-13 |
| Returned To Mfg | 2017-06-19 |
| Catalog Number | 100/905/300 |
| Lot Number | 150112 |
| Device Expiration Date | 2018-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2017-04-13 |