FDA Adverse Event
Death
Summary report: N
AQUA SEAL CHEST DRAINAGE UNIT
MDR report key: 172541
·
Received June 17, 1998
Report
- Report Number
- 9611018-1998-00008
- Event Type
- Death
- Date Received
- June 17, 1998
- Date of Event
- June 11, 1998
- Report Date
- June 12, 1998
- Manufacturer
- SHERWOOD MEDICAL INDUSTRIES
- Product Code
- KDQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
REFERENCE MFR. COMPLAINT #98061603TL. THE ACTUAL SAMPLE WAS RETURNED. IT WAS TOO CONTAMINATED FOR PHYSICAL TESTING. HOWEVER, VISUAL EXAMINATION FOUND NO DEFECTS. R&D CHECKED THE UNIT AND REPORTED IT HAD TO HAVE FUNCTIONED PROPERLY TO ENABLE THE STAFF TO TRANSFUSE THE PT. BLOOD BAG WAS COMPLETELY DRY, INDICATING THE STAFF DID NOT FOLLOW MFG INSTRUCTIONS. "BLOOD SHOULD NOT BE INFUSED BELOW 50CC TO PREVENT AIR EMBOLISM FROM OCCURRING." THIS APPEARS TO BE A CASE OF USER ERROR.
Description of Event or Problem · 1
FOLLOW UP WITH THE CUSTOMER FOUND THE UNIT SET UP WAS GOOD AND THE IV SET UP LOOKED GOOD. HOWEVER, THE BLOOD BAG, WHICH HAD A PRESSURE INFUSION CUFF ATTACHED, WAS COMPLETELY DRY. THE UNIT WAS PHOTOGRAPHED BY THE HOSP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AQUA SEAL CHEST DRAINAGE UNIT | CHEST DRAINAGE SYSTEM | KDQ | SHERWOOD MEDICAL INDUSTRIES | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Death |