MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-24 for SAPH AP102 2SPIKE BLD W/200FLTR CLAV YS 163479255 manufactured by Icu Medical Costa Rica Ltd..
[186808188]
The device was received on february 18, 2020. The investigation and test results are pending.
Patient Sequence No: 1, Text Type: N, H10
[186808189]
The customer reported a sapphire h100 infusion pump and sapphire administration set that the pump did not alarm for air in line and the air passed to the patient. It was reported after delivering blood, the nurse programmed the cleaning serum to a rate of 200ml/h, vtbi 100 ml, time 30 minutes and went out of the room. There was less than 100ml in the bag. The pump alarmed an unspecified alarm, and the nurse went back into the room noticing the set was completely primed with air. The nurse reported the pump didn't stop because it was making the functioning noise and does not remember the displayed alarm message. The nurse stopped the pump and disconnected it from the patient. A doctor went to visit the patient and to check her status and the patient was fine. The pump was at a height of approximately 1. 20m, the bag at approximately 1. 70m, and the patient was in bed. There was no harm, no need for medical intervention, and no delay in critical therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615050-2020-00033 |
| MDR Report Key | 9746858 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2020-02-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTOPHER ZANONI |
| Manufacturer Street | 600 N. FIELD DR. |
| Manufacturer City | LAKE FOREST IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 2247062300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAPH AP102 2SPIKE BLD W/200FLTR CLAV YS |
| Generic Name | ACCESSORIES, PUMP, INFUSION |
| Product Code | MRZ |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-02-18 |
| Catalog Number | 163479255 |
| Lot Number | 905985H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL COSTA RICA LTD. |
| Manufacturer Address | ZONA FRANCA GLOBAL LA AURORA HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |